Asfiled with the Securities and Exchange Commission on May 1,2020

RegistrationNo. 333-

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM S-3

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

VISTAGEN THERAPEUTICS, INC.

(Exactname of registrant as specified in its charter)

Nevada

2834

20-5093315

(Stateor Other Jurisdiction of

Incorporationor Organization)

(PrimaryStandard Industrial

ClassificationCode Number)

(I.R.S.Employer

IdentificationNumber)

343 Allerton Ave.

South San Francisco, California 94090

(650) 577-3600

(Address,including zip code, and telephone number,

includingarea code, of registrants principal executiveoffices)

Shawn K. Singh

Chief Executive Officer

VistaGen Therapeutics, Inc.

343 Allerton Avenue

South San Francisco, California 94080

(650) 577-3600

(Name,address, including zip code, and telephone number,

includingarea code, of agent for service)

Copies to

Daniel W. Rumsey, Esq.

Jessica R. Sudweeks, Esq.

Disclosure Law Group, a Professional Corporation

655 West Broadway, Suite 870

San Diego, CA 92101

Telephone: (619) 272-7050

Facsimile: (619) 330-2101

Approximate date of commencement of proposed sale to thepublic: As soon as practicable after this registrationstatement becomes effective.

If the only securities being registered on this form are beingoffered pursuant to dividend or interest reinvestment plans, pleasecheck the following box.

If any of the securities being registered on this form are to beoffered on a delayed or continuous basis pursuant to Rule 415 underthe Securities Act of 1933, other than securities offered only inconnection with dividend or interest reinvestment plans, check thefollowing box.

If this form is filed to register additional securities for anoffering pursuant to Rule 462(b) under the Securities Act of 1933,please check the following box and list the Securities Actregistration statement number of the earlier effective registrationstatement for the same offering.

If this form is a post-effective amendment filed pursuant to Rule462(c) under the Securities Act, check the following box and listthe Securities Act registration statement number of the earliereffective registration statement for the sameoffering.

If this form is a registration statement pursuant to GeneralInstruction I.D. or a post-effective amendment thereto that shallbecome effective upon filing with the Commission pursuant to Rule462(e) under the Securities Act, check the followingbox.

If this form is a post-effective amendment to a registrationstatement filed pursuant to General Instruction I.D. filed toregister additional securities or additional classes of securitiespursuant to Rule 413(b) under the Securities Act, check thefollowing box.

Indicateby check mark whether the registrant is a large accelerated filer,an accelerated filer, a non-accelerated filer, smaller reportingcompany, or an emerging growth company. See the definitions oflarge accelerated filer, acceleratedfiler, smaller reporting company, andemerging growth company in Rule 12b-2 of the ExchangeAct.

Largeacceleratedfiler

[]

Acceleratedfiler

[]

Non-acceleratedfiler

[ ]

Smallerreportingcompany

[X]

Emerginggrowth company

[ ]

If anemerging growth company, indicate by check mark if the registranthas elected not to use the extended transition period for complyingwith any new or revised financial accounting standards providedpursuant to Section 13(a) of the Exchange Act.

CALCULATION OF REGISTRATION FEE

Titleof each class of securities to be registered

Amountto

be

registered(1)(2)

Proposed

maximum

offeringprice per

share(3)

Proposed

Original post:
VistaGen Therapeutics, Inc. S-3 May. 1, 2020 4:59 PM - Seeking Alpha

Cardiac Stem Cells Comments Off on VistaGen Therapeutics, Inc. S-3 May. 1, 2020 4:59 PM – Seeking Alpha | May 3rd, 2020

Earlier, treating orthopedic problems just led to temporary cure but not the root cause of the problem. However, the case is not the same now. With emerging research and experience, Dr. David C. Karli says that regenerative medicine can completely repair the tissues using stem cell therapies. From professional athletes to ordinary people who strive to live a healthy and active life, regenerative medicine is a new ray of hope providing a healthy alternative for sports and musculoskeletal conditions and injuries.

Dr. David C. Karli is an Ivy-trained physician, a pioneer in orthopedic regenerative medicine and sports medicine, and the founder of Greyledge Technologies, one of the first FDA-audited biotech companies that prepare biologic implants to repair humans diseased or damaged tissues. Talking about the advancements in regen medicine, he says, Regenerative medicines multidisciplinary approach can cater to solutions for several untreatable orthopedic problems. With experts around the world pooling their knowledge, skills, and resources, a breakthrough in orthopedic treatment is leading to a miracle cure.

What is Regenerative Medicine?

Regenerative medicine is an interdisciplinary field that helps repair or replaces damaged or diseased human cells or tissues to restore normal function. The relatively new field of study comprises a broad range of scientific disciplines like molecular biology and genetics to immunology and biochemistry. Dr. Karli specializes in orthopedic applications where a patients diseased cells are replaced and re-implanted by the autologously collected healthy cells from the same patient.

About Dr. David C. Karli

Dr. David Karli graduated from Elizabethtown College, Pennsylvania, in 1993. Followed by receiving his MD degree from the University of Maryland, he pursued his residency in physical medicine and rehabilitation at Harvard Medical School, where he served as a chief resident in his final year. While serving as an attending physician at Harvard Medical School, Dr. Karli collaborated with his orthopedic surgeon colleagues and participated in the development of rehabilitation protocols for spinal disorders. He joined the Steadman Clinic in Vail, Colorado, where his research interest led him to take up Regenerative Medicine and successfully launch and develop Greyledge Technologies. This company focuses on autologous blood-based biotherapies for orthopedic injuries.

In his 23 years of experience, Dr. Karli has authored several research papers and publications on stem cell therapies and rehabilitation and lectured on spinal and musculoskeletal topics. He is a Diplomate of the American Board of Physical Medicine and Rehabilitation. Also, Dr. Karli is an active member of several societies, including the Regenerative Medicine Organization., the American Academy of PM&R, and the International Spinal Injection Society.

Greyledge Technologies

He founded the company Greyledge Technologies in 2010 with the mission to redefine orthopedic treatments and enhance the bodys response to injury. Greyledge Technologies develops biologic products by processing materials like human blood and bone marrow into implantable preparations. These biologic preparations are further developed and inserted into the human body replacing the diseased cells hence, stimulating the healing process and self-repair.

At Greyledge Technologies, every patient is completely assessed and analyzed not only to guarantee that theyre fit to undergo the procedure yet additionally to create a personalized dynamic strategy that each patient can follow. The whole treatment takes a certain number of days wherein the family members and caretakers are informed about the medicinal dosages to follow after the procedure. After surgery, every patient is regularly followed-up by the rehabilitation team.

When asked in-depth about practicing regenerative medicine at Greyledge Technologies, Dr. Karli said, The treatment is entirely safe and effective as it requires no big surgeries or complicated operations. As the cells used are autologous, they do not pose any chances of immune rejection or untoward irreversible side effects. Neither do the cells need to be preserved. This makes the procedure swift and safe for all ages.

Dr. Karli says, Regenerative Medicine is emerging as one of the trending treatment options for patients who have lost all hope. Whats brilliant about this treatment is that it has the capability to thoroughly repair the damaged tissues at the molecular, structural, and functional level.

Related

https://www.youtube.com/watch?v=ITupYOWaNF8&feature=youtu.beAfter first breaking out onto the scene as one of MTVs first PUSH Live! performers last year, hip-hop sensationJack Harlowis

Young Money Radio with Lil Waynereturns to Apple Music today with more exclusive mixes and special guests.Tune in to Young

Hannibal Buress has shared his latest single "Judge Judy" featuring frequent collaborator Ron Lamont. The track produced by Chrome Sparks

Originally posted here:
David C. Karli is Offering a New Ray of Hope Through Regenerative Medicine - RESPECT.

Bone Marrow Stem Cells Comments Off on David C. Karli is Offering a New Ray of Hope Through Regenerative Medicine – RESPECT. | May 3rd, 2020

DetailsCategory: AntibodiesPublished on Saturday, 02 May 2020 12:42Hits: 149

- Innovative, fixed-dose formulation significantly reduces treatment time from hours to minutes and demonstrates consistent efficacy with a reduction in administration-related reactions compared to DARZALEX (daratumumab) for approved indications

- DARZALEX FASPRO is the only subcutaneous CD38-directed antibody approved in the treatment of multiple myeloma

HORSHAM, PA, USA I May 1, 2020 I The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approved DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a new subcutaneous formulation of daratumumab. DARZALEX FASPRO is approved in four regimens across five indications in multiple myeloma patients, including newly diagnosed, transplant-ineligible patients as well as relapsed or refractory patients.As a fixed-dose formulation, DARZALEX FASPRO can be administered over approximately three to five minutes, significantly less time than DARZALEX,which is given intravenously over hours. In the Phase 3 COLUMBA study supporting the approval, DARZALEX FASPRO demonstrated a consistent overall response rate (ORR) and pharmacokinetics and a similar safety profile compared with intravenous DARZALEX in patients with relapsed or refractory multiple myeloma. In addition, there was a nearly two-thirds reduction in systemic administration-related reactions (ARRs) for DARZALEX FASPRO compared to intravenous DARZALEX (13 percent vs. 34 percent, respectively).

"This approval exemplifies Janssen's mission and commitment to bringing together passion, science and ingenuity to advance novel solutions for patients," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, LLC. "We are excited about the potential of this meaningful innovation in transforming the treatment experience for patients with multiple myeloma where DARZALEX FASPRO can be administered in approximately three to five minutes, significantly less time than intravenous DARZALEX, which is given over hours. Based on its favorable profile, we are accelerating the development of DARZALEX FASPRO and evaluating its potential in multiple ongoing studies."

Click to Tweet: #NEWS: #FDA approves subcutaneous CD38-directed antibody for the treatment of multiple #myeloma. See here for more details: https://bit.ly/2VozhzY

The approval is based on data from the Phase 3 COLUMBA (MMY3012)and Phase 2 PLEIADES (MMY2040) studies.1,2 In the COLUMBA study, the ORR was non-inferior for patients taking DARZALEX FASPROas monotherapycompared to those taking intravenous DARZALEXas monotherapy (41 percent vs. 37 percent, respectively). In addition, there were fewer systemic ARRs with DARZALEX FASPRO versus intravenous DARZALEX (13 percent vs. 34 percent, respectively). In a pooled safety population of 490 patients who received DARZALEXFASPRO as monotherapy or in combination, the ARR rate wFas 11 percent. The safety profiles of intravenous DARZALEX and DARZALEX FASPRO were otherwise similar.1 Additionally, in the Phase 2 PLEIADES study evaluating the efficacy and safety of DARZALEX FASPRO in combination therapies, objective responses were demonstrated in combination with bortezomib, melphalan and prednisone (D-VMP) in newly diagnosed transplant ineligible patients. In addition, objective responses were demonstrated in combination with lenalidomide and dexamethasone (D-Rd) in relapsed or refractory patients who received one prior line of therapy.2

"The Multiple Myeloma Research Foundation shares a common goal with Janssen in advancing treatments for multiple myeloma and addressing the unmet needs of this patient community," said Paul Giusti, President and CEO of the Multiple Myeloma Research Foundation (MMRF). "The approval of DARZALEXFASPRO marks an important milestone which will help make a positive difference in the lives of patients who depend on this effective therapy."

Click to Tweet: .@theMMRF talks about advancing treatments for multiple #myeloma and addressing patient needs with latest #FDA approval. Read more here: https://bit.ly/2VozhzY

"Since the approval of daratumumab, a robust body of evidence has established its use as a treatment for multiple myeloma in both the frontline and relapsed and refractory settings," said Saad Z. Usmani, M.D., Division Chief of Plasma Cell Disorders, Levine Cancer Institute. "With DARZALEX FASPRO there may be fewer administration-related reactions compared to intravenous DARZALEX, providing an additional treatment option that may help patients, oncologists and nursing staff."

DARZALEX FASPROis co-formulated with recombinant human hyaluronidase PH20 (rHuPH20) [Halozyme'sENHANZEdrug delivery technology].DARZALEX FASPRO will be available to patients and physicians as soon as the week of May 11, 2020. The intravenous DARZALEX formulation will also remain available as an option for patients and their physicians.

DARZALEX FASPROis approved in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant, in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy, in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy, as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.

The U.S. FDA approval of DARZALEX FASPRO marks the first approval for this innovative subcutaneous formulation globally, and Janssen continues to work with health authorities around the world in an effort to bring this new treatment option to patients living with multiple myeloma.

Access to DARZALEX FASPRO (daratumumab and hyaluronidase-fihj)Janssen offers comprehensive access and support information, resources and services to assist U.S. patients in gaining access to DARZALEX FASPROthrough the Janssen CarePath Program. Through the program, eligible commercial patients pay no more than $5 per injection, regardless of individual income level. Information on the enrollment process is available online atwww.CarePathSavingsProgram.com/DARZALEX.

For more information, healthcare providers or patients can contact: 1-844-55DARZA (1-844-553-2792). Information will also be available atwww.DARZALEX.com. Dedicated case coordinators are available to work with both healthcare providers and patients.

About the COLUMBA Study 1The randomized, open-label, multicenter Phase 3 COLUMBA study (MMY3012) included 522 patients (median age of 67 years) with multiple myeloma who had received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or whose disease was refractory to both a PI and an IMiD. In the arm that received DARZALEX FASPRO(n=263), patients received a fixed dose of DARZALEX FASPRO1,800 milligrams (mg), co-formulated with recombinant human hyaluronidase PH20 (rHuPH20) 2,000 Units per milliliter (U/mL), subcutaneously weekly for Cycles 1 2, every two weeks for Cycles 3 6 and every four weeks for Cycle 7 and thereafter. In the intravenous DARZALEXarm (n=259), patients received DARZALEXfor intravenous infusion 16 milligrams per kilogram (mg/kg) weekly for Cycles 1 2, every two weeks for Cycles 3 6 and every four weeks for Cycle 7 and thereafter. Each cycle was 28 days. In the arm that received DARZALEX FASPRO, itwas given in a fixed volume of 15 mL over three to five minutes; the median injection time was five minutes. In the arm that received theintravenous administration, the median durations of the first, second and subsequent intravenous DARZALEXinfusions were 7.0, 4.3 and 3.4 hours, respectively.Patients in both arms continued treatment until disease progression or unacceptable toxicity.

About the PLEIADES Study 2The non-randomized, open-label, parallel assignment Phase 2 PLEIADES study (MMY2040) included more than 240 adults with multiple myeloma, including 67 patients with newly diagnosed multiple myeloma who were treated with 1,800 mg of DARZALEX FASPROin combination with bortezomib, melphalan, and prednisone (D-VMP) and 65 patients with relapsed or refractory disease who were treated with 1,800 mg of DARZALEX FASPROplus lenalidomide and dexamethasone (D-Rd). The primary endpoint for the D-VMP and D-Rd cohorts was overall response rate.

About DARZALEXand DARZALEX FASPROJanssen is committed to exploring the potential of DARZALEX (daratumumab) for patients with multiple myeloma across the spectrum of the disease. DARZALEX has been approved in seven indications, three of which are in the frontline setting, including newly diagnosed patients who are transplant eligible and ineligible.

DARZALEX has become a backbone therapy in the treatment of multiple myeloma, having been used in the treatment of more than 58,000 patients in the U.S. alone since its U.S. FDA approval in 2015. DARZALEX is the first CD38-directed antibody approved globally to treat multiple myeloma and in 2020, DARZALEX FASPRO(daratumumab and hyaluronidase human-fihj) follows as the only subcutaneous CD38-directed antibody approved to treat patients with multiple myeloma.2

CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease.4 DARZALEX binds to CD38 and inhibits tumor cell growth causing myeloma cell death.5 DARZALEX may also have an effect on normal cells.3 Data across seven Phase 3 clinical trials, in both the frontline and relapsed settings, have shown that DARZALEX-based regimens resulted in significant improvement in progression-free survival and/or overall survival. 4,5,6,7,8,9,10,11 Additional studies are underway to assess the efficacy and safety of DARZALEXFASPRO in the treatment of other malignant and pre-malignant hematologic diseases in which CD38 is expressed, including smoldering myeloma and in amyloidosis.12,13

Key DARZALEX Milestones:

Please see full Prescribing Information at http://www.DARZALEX.com.

About Multiple MyelomaMultiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.21,22When damaged, these plasma cells rapidly spread and replace normal cells with tumors in the bone marrow. In 2020, it is estimated that 32,270 people will be diagnosed and 12,830 will die from the disease in the U.S.24 While some patients with multiple myeloma have no symptoms, most patients are diagnosed due to symptoms, which can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems or infections.23

Please see full Prescribing Information at http://www.DARZALEX.com.

About the Janssen Pharmaceutical Companies of Johnson & Johnson At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Learn more at http://www.janssen.com. Follow us at http://www.twitter.com/JanssenGlobal. Janssen Research & Development, LLC and Janssen Biotech, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

ENHANZEis a registered trademark of Halozyme.

1Mateos M-V et al. Efficacy and Safety of the Randomized, Open-Label, Non-inferiority, Phase 3 Study of Subcutaneous (SC) Versus Intravenous (IV) Daratumumab (DARA) Administration in Patients (pts) With Relapsed or Refractory Multiple Myeloma (RRMM): COLUMBA. 2019 American Society of Clinical Oncology Annual Meeting. June 2019.

2Janssen Research & Development, LLC. A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000 [cited July 5, 2019]. Available at: https://clinicaltrials.gov/ct2/show/NCT03412565. Identifier: NCT03412565.

32020Fedele G et al. CD38 Ligation in Peripheral Blood Mononuclear Cells of Myeloma Patients Induces Release of Protumorigenic IL-6 and Impaired Secretion of IFN Cytokines and Proliferation. Mediators Inflamm. 2013;564687.

4Janssen Research & Development, LLC. A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02076009?term=mmy3003&rank=1 Identifier: NCT02136134 .

5Janssen Research & Development, LLC. Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02136134?term=mmy3004&rank=1 Identifier: NCT02076009.

6Janssen Research & Development, LLC. A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma (Cassiopeia). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02541383?term=mmy3006 Identifier: NCT02541383.

7Janssen Research & Development, LLC. A Study of Combination of Daratumumab and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Participants With Previously Untreated Multiple Myeloma In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02195479?term=mmy3007&rank=1 Identifier: NCT02195479.

8Janssen Research & Development, LLC. Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02252172?term=mmy3008&rank=1 Identifier: NCT02252172.

9Janssen Research & Development, LLC. A Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Participants With Previously Untreated Multiple Myeloma Who Are Ineligible for High-Dose Therapy (Asia Pacific Region). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT03217812?term=MMY3011&rank=1 Identifier: NCT03217812.

10European Myeloma Network. Compare Progression Free Survival Btw Daratumumab/Pomalidomide/Dexamethasone vs Pomalidomide/Dexamethasone (EMN14). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24] Available at: https://clinicaltrials.gov/ct2/show/NCT03180736?term=MMY3013&rank=2 Identifier: NCT03180736

11Amgen. Study of Carfilzomib, Daratumumab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma. (CANDOR). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24] Available at: https://clinicaltrials.gov/ct2/show/NCT03158688?term=NCT03158688&rank=1 Identifier: NCT03158688.

12Janssen Research & Development, LLC. A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants With Smoldering Multiple Myeloma In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 March 19]. Available at: https://clinicaltrials.gov/ct2/show/NCT02316106?term=smm2001&rank=1 Identifier: NCT02316106.

13Janssen Research & Development, LLC. An Efficacy and Safety Proof of Concept Study of Daratumumab in Relapsed/Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 March 19]. Available at: https://clinicaltrials.gov/ct2/show/NCT02413489?term=lym2001&rank=1 Identifier: NCT02413489

14Janssen Biotech, Inc. "Janssen Biotech Announces Global License and Development Agreement for Investigational Anti-Cancer Agent Daratumumab." Issued August 30, 2012.

15Janssen Biotech, Inc. "DARZALEX (daratumumab) Approved by U.S. FDA: First Human Anti-CD38 Monoclonal Antibody Available for the Treatment of Multiple Myeloma." Issued November 16, 2015.

16Janssen Biotech, Inc. "DARZALEX (daratumumab) Approved by U.S. FDA in Combination with Two Standard of Care Regimens for the Treatment of Patients with Multiple Myeloma Who Have Received At Least One Prior Therapy." Issued November 21, 2016.

17Janssen Biotech, Inc. "DARZALEX (daratumumab) Approved by the U.S. FDA in Combination with Pomalidomide and Dexamethasone for Patients with Multiple Myeloma Who Have Received At Least Two Prior Therapies." Issued June 16, 2017.

18Janssen Biotech, Inc. "Janssen Announces DARZALEX (daratumumab) U.S. FDA Approval for Newly Diagnosed Patients with Multiple Myeloma who are Transplant Ineligible." Issued May 7, 2018.

19Janssen Biotech, Inc. "Janssen Announces U.S. FDA Approval of DARZALEX (daratumumab) in Combination with Lenalidomide and Dexamethasone for Newly Diagnosed Patients with Multiple Myeloma Who Are Transplant Ineligible." Issued June 27, 2019.

20Janssen Biotech, Inc. "Janssen Announces U.S. FDA Approval of DARZALEX (daratumumab) Combination Regimen for Newly Diagnosed, Transplant-Eligible Patients with Multiple Myeloma." Issued September 26, 2019.

21Kumar, SK et al. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012 Jan; 26(1):149-57.

22American Cancer Society. "What Is Multiple Myeloma?" Available at: http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-is-multiple-myeloma. Accessed June 2019.

23American Cancer Society. "Key Statistics About Multiple Myeloma." Available at: https://www.cancer.org/cancer/multiple-myeloma/about/key-statistics.html. Accessed January 2020.

SOURCE: Janssen

View original post here:
US Food and Drug Administration Approves DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a New Subcutaneous Formulation of Daratumumab in the...

Bone Marrow Stem Cells Comments Off on US Food and Drug Administration Approves DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a New Subcutaneous Formulation of Daratumumab in the… | May 2nd, 2020

Aging is an inevitable process. We cannot escape or prevent getting older but what if theres a fascinating field of medicine that can manage the aging process and prolong our health and vitality and longevity as we age?

Aging is an inevitable process. We cannot escape or prevent getting older but what if theres a fascinating field of medicine that can manage the aging process and prolong our health and vitality and longevity as we age?

Keeping in mind that there may never be an approach to totally stop or reverse aging, there have been some surprising disclosures to how Regenerative Medicine can naturally heal our body without the use of any surgical procedure.

Rejuvenating Old Cells to Healthy ones

The paces, stresses, and complexities in life drive us to age prematurely thereby breaking down our cells. Cell breakdown may lead to several health conditions like cancer, heart disease, Alzheimers and others.

Driving our bodies to age quickly, cell-breakdown is host to many age-related diseases, causing more than 100,000 deaths per day.

Dr David C Karli is an Ivy-trained physician, specialized in treating athletic injuries by inducing regenerative medicine and stem cell therapy in treatments.

He accepts the fact that patients can increase an additional 30 years of life by using Regenerative Medicine. One such innovation uses stem cells, however, there are issues with these cells.

They may not replace the original, diseased cells rapidly enough, or they may start to replicate uncontrollably, bringing about malignant growth.

Yet, Regenerative Medicine definitely guarantees the complete curing of a wide range of diseases, and ideally, slowing down the aging process too.

Stem Cell Therapy Programs with Promising Results

With solid funding and rapid advancements, one stem cell therapy that promises great outcomes is transfusions. In this therapy, stem cells are extracted from the patient and grown in cell culture to increase the number of cells. Following this, those cells are injected back into the patients body.

Dr. Karlis keen interest in Transfusions led him to create biologic products that can cause an age-related decline in a persons strength, endurance, and various other physical abilities.

At his biotech firm, Greyledge Technologies, biologic products are prepared by processing materials (blood or bone marrow) and implanting them into the human body to replicate the diseased tissues.

With an FDA-registered laboratory environment, the outcomes are promising and are an anti-aging protocol.

Telomeres may be the next-gen solution for Anti Aging

Telomeres are essential parts of our DNA that are connected to the premature aging cells. Situated at the end caps of our DNA strands, the information within Telomeres is lost while DNA replicates to the extent that they stop replicating.

If DNA replicates without losing information, scientists believe that Telomeres can significantly help to slow down the aging process.

Similar is the case with Metformin, a pharmaceutical reagent that improves wound healing. Proven to counteract aging, Metformin is now being tested for its unique ability to mimic calorie restriction.

Anti-Aging Through Regeneration

Utilizing induced tissue regeneration, this technology is a new approach to anti-aging treatment. Combining telomerase therapy and induced tissue regeneration, anti-aging through regeneration includes the study of the impact on age-related diseases like diabetes, metabolic disorders, cardiovascular disease, and others.

This technique focuses on the cells that are generated in our body during youth. As we age, these cells are lost and lead to a metabolic imbalance.

Scientists and Researchers are trying to find a way in which these cells can be restored to reverse the signs of aging and create a balance.

Humans have the ability to regenerate damaged and diseased tissues. However, this only happens during the first few weeks of development. With the help of Artificial Intelligence, scientists are trying to unlock this potential ability in humans.

The Future of Anti-Aging

With several breakthroughs on the horizon, cure-all promises and best outcomes, these anti-aging protocols have a long way to go.

While the introduction of regenerative medicine and stem cell therapies to redefine orthopedic treatment sounds like a miracle, there are still unexplored paths that need to be taken.

With all the benefits regenerative medicine has to offer, there will always be an eye on the never-ending search for the fountain of youth.

CLICK HERE FOR BREVARD COUNTY NEWS

Read more here:
Dr. David C. Karli's Opinion on Regenerative Medicine and Age Prevention | - SpaceCoastDaily.com

Bone Marrow Stem Cells Comments Off on Dr. David C. Karli’s Opinion on Regenerative Medicine and Age Prevention | – SpaceCoastDaily.com | May 2nd, 2020

Thursday, May 7, 2020, 8:30 a.m. EDT

NEW YORK, April 29, 2020 (GLOBE NEWSWIRE) -- BrainStorm-Cell Therapeutics Inc.(NASDAQ: BCLI), a leader in developing innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, announced today, that the Company will hold a conference call to update shareholders on financial results for the first quarter endedMarch 31, 2020, and provide a corporate update, at 8:30 a.m, Eastern Daylight Time, onThursday, May 7, 2020.

BrainStorms CEO,Chaim Lebovits, will present a corporate update, after which, participant questions will be answered. Joining Mr. Lebovits to answer investment community questions will beRalph Kern, MD, MHSc, President and Chief Medical Officer, David Setboun, PhD, MBA, Executive Vice President and Chief Operating Officer andPreetam Shah, PhD, MBA, Executive Vice President and Chief Financial Officer.

Participants are encouraged to submit their questions prior to the call by sending them to:q@brainstorm-cell.com. Questions should be submitted by5:00 p.m. EDT, Tuesday, May 5, 2020.

Teleconference Details BRAINSTORM CELL THERAPEUTICS 1Q 2020

The investment community may participate in the conference call by dialing the following numbers:

Those interested in listening to the conference call live via the internet may do so by visiting the "Investors & Media" page of BrainStorm's website at http://www.ir.brainstorm-cell.com and clicking on the conference call link.

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available for 14 days.

ABOUT NUROWNNurOwn (autologous MSC-NTF cells) represent a promising investigational approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. NurOwn is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.

ABOUT BRAINSTORM CELL THERAPEUTICS INC.:BrainStorm Cell Therapeutics Inc.is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwnCellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. Autologous MSC-NTF cells have received Orphan Drug status designation from theU.S. Food and Drug Administration(U.S.FDA) and theEuropean Medicines Agency(EMA) in ALS. BrainStorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in theU.S., supported by a grant from theCalifornia Institute for Regenerative Medicine(CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S.FDAapproval of autologous MSC-NTF cells in ALS. BrainStorm received U.S.FDAclearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) inDecember 2018and has been enrolling clinical trial participants sinceMarch 2019. For more information, visit the company'swebsite.

SAFE HARBOR STATEMENT:Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could causeBrainStorm Cell Therapeutics Inc.'sactual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorms need to raise additional capital, BrainStorms ability to continue as a going concern, regulatory approval of BrainStorms NurOwn treatment candidate, the success of BrainStorms product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorms NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorms ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorms ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Story continues

Read more here:
BrainStorm-Cell Therapeutics to Announce First Quarter Financial Results and Provide a Corporate Update - Yahoo Finance

Bone Marrow Stem Cells Comments Off on BrainStorm-Cell Therapeutics to Announce First Quarter Financial Results and Provide a Corporate Update – Yahoo Finance | May 2nd, 2020

Cytokines are the cell signaling molecules which are secreted from the different body cells. Cytokines are the proteins which play an important role of messenger between cells and regulates various physiological and metabolic activities. Cytokines regulate various inflammatory responses, stimulate blood cells production, and stimulate tissue development & maintenance. Cytokine is a large family of the small protein which includes tumors necrosis factor, interleukins, interferons, lymphokines and chemokines. Cytokines are produced by a wide range of cells includes cells like macrophages, lymphocytes, T lymphocytes, endothelial cells, mast cells, fibroblasts, stromal cells and cells. Some cytokines developed into protein therapeutics to treat bone-related disorders, anemia, cancer, infection, multiple sclerosis. Cytokine is most commonly used in the research & development activities in the field of life sciences and drug development.

Request to Sample report @ https://www.persistencemarketresearch.com/samples/30223

Increasing research and development activities expected to favour the growth of the cytokines market. As well as growing life science research funding boost up the growth of the cytokines market. Increasing prevalence of diseases such as cancer and skin disorders expected to drive the growth of the cytokines market. The growing demand for regenerative medicines impels the growth of the cytokines market. The growing demand for cytokines for wound management and cancer therapeutics expected to drive the growth of the market. Growing funding for cancer-based research influencing the growth of cytokines market. Growing cell culture-based research activities and increasing demand for cytokines in stem cell biology are major factors expected to drive the growth of the cytokines market. Growing manufacturers investments in cell culture media production expected to favour the growth of the growth factors market over the forecast period. Growing strategic acquisition and merger activities among market players is the major trend in the cytokines market. The high cost of research-based cytokines products is the major factor expected to restrain the growth of the cytokines market.

Request PMR insights on measuring the impact of COVID-19 coronavirus across industries.

The global cytokines market is segmented on basis of product type, application, end users and region:

Cytokine is the large family of cytokines includes tumour necrosis factor-TNF, interleukins (IL), interferons, chemokines and other cytokines. Interleukins (IL) is the most commonly used cytokine and have large family. IL-1 family, IL-4 family, IL-6 family, IL-10 family are mostly commonly used interleukins family in the research. Cytokines are used in various field of the research such as dermatology, cancer, orthopedics, respiratory and other fields. Cytokines are used for the research application among end users such as pharmaceutical & biotechnology companies, contract research organizations and academic & research institutes.

North America expected to dominate the global cytokines market as increasing demand for cytokines products as increasing research and development activities. Europe expected to contribute second-highest revenue share in global cytokines market as a growing number of clinical trial and drug development activities. The Asia Pacific expected to grow with the highest growth rate in the cytokines market as an increasing number of pharmaceutical manufacturers, biotechnology companies and academic institutions in the Asia Pacific region. India, South Korea & China cytokines market expected to grow with a higher growth rate as growing research and development funding from the government. The Middle East & Africa cytokines market expected to grow with the lowest growth rate due to lack of research and development activities in the region.

Request to View TOC @ https://www.persistencemarketresearch.com/toc/30223

Some of the players operating in the global cytokines market are ,

For in-depth competitive analysis, buy [emailprotected] https://www.persistencemarketresearch.com/checkout/30223

See the rest here:
Increasing Demand for Cytokines Market to Substantially Surge the Revenues Through the COVID-19 Lockdown Phase and Forecast 2019 2029 Cole Reports -...

Skin Stem Cells Comments Off on Increasing Demand for Cytokines Market to Substantially Surge the Revenues Through the COVID-19 Lockdown Phase and Forecast 2019 2029 Cole Reports -… | May 2nd, 2020

Updated: May 25, 2018:

JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.

This Privacy Policy describes how JD Supra, LLC ("JD Supra" or "we," "us," or "our") collects, uses and shares personal data collected from visitors to our website (located at http://www.jdsupra.com) (our "Website") who view only publicly-available content as well as subscribers to our services (such as our email digests or author tools)(our "Services"). By using our Website and registering for one of our Services, you are agreeing to the terms of this Privacy Policy.

Please note that if you subscribe to one of our Services, you can make choices about how we collect, use and share your information through our Privacy Center under the "My Account" dashboard (available if you are logged into your JD Supra account).

Registration Information. When you register with JD Supra for our Website and Services, either as an author or as a subscriber, you will be asked to provide identifying information to create your JD Supra account ("Registration Data"), such as your:

Other Information: We also collect other information you may voluntarily provide. This may include content you provide for publication. We may also receive your communications with others through our Website and Services (such as contacting an author through our Website) or communications directly with us (such as through email, feedback or other forms or social media). If you are a subscribed user, we will also collect your user preferences, such as the types of articles you would like to read.

Information from third parties (such as, from your employer or LinkedIn): We may also receive information about you from third party sources. For example, your employer may provide your information to us, such as in connection with an article submitted by your employer for publication. If you choose to use LinkedIn to subscribe to our Website and Services, we also collect information related to your LinkedIn account and profile.

Your interactions with our Website and Services: As is true of most websites, we gather certain information automatically. This information includes IP addresses, browser type, Internet service provider (ISP), referring/exit pages, operating system, date/time stamp and clickstream data. We use this information to analyze trends, to administer the Website and our Services, to improve the content and performance of our Website and Services, and to track users' movements around the site. We may also link this automatically-collected data to personal information, for example, to inform authors about who has read their articles. Some of this data is collected through information sent by your web browser. We also use cookies and other tracking technologies to collect this information. To learn more about cookies and other tracking technologies that JD Supra may use on our Website and Services please see our "Cookies Guide" page.

We use the information and data we collect principally in order to provide our Website and Services. More specifically, we may use your personal information to:

JD Supra takes reasonable and appropriate precautions to insure that user information is protected from loss, misuse and unauthorized access, disclosure, alteration and destruction. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. You should keep in mind that no Internet transmission is ever 100% secure or error-free. Where you use log-in credentials (usernames, passwords) on our Website, please remember that it is your responsibility to safeguard them. If you believe that your log-in credentials have been compromised, please contact us at privacy@jdsupra.com.

Our Website and Services are not directed at children under the age of 16 and we do not knowingly collect personal information from children under the age of 16 through our Website and/or Services. If you have reason to believe that a child under the age of 16 has provided personal information to us, please contact us, and we will endeavor to delete that information from our databases.

Our Website and Services may contain links to other websites. The operators of such other websites may collect information about you, including through cookies or other technologies. If you are using our Website or Services and click a link to another site, you will leave our Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We are not responsible for the data collection and use practices of such other sites. This Policy applies solely to the information collected in connection with your use of our Website and Services and does not apply to any practices conducted offline or in connection with any other websites.

JD Supra's principal place of business is in the United States. By subscribing to our website, you expressly consent to your information being processed in the United States.

You can make a request to exercise any of these rights by emailing us at privacy@jdsupra.com or by writing to us at:

You can also manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard.

We will make all practical efforts to respect your wishes. There may be times, however, where we are not able to fulfill your request, for example, if applicable law prohibits our compliance. Please note that JD Supra does not use "automatic decision making" or "profiling" as those terms are defined in the GDPR.

Pursuant to Section 1798.83 of the California Civil Code, our customers who are California residents have the right to request certain information regarding our disclosure of personal information to third parties for their direct marketing purposes.

You can make a request for this information by emailing us at privacy@jdsupra.com or by writing to us at:

Some browsers have incorporated a Do Not Track (DNT) feature. These features, when turned on, send a signal that you prefer that the website you are visiting not collect and use data regarding your online searching and browsing activities. As there is not yet a common understanding on how to interpret the DNT signal, we currently do not respond to DNT signals on our site.

For non-EU/Swiss residents, if you would like to know what personal information we have about you, you can send an e-mail to privacy@jdsupra.com. We will be in contact with you (by mail or otherwise) to verify your identity and provide you the information you request. We will respond within 30 days to your request for access to your personal information. In some cases, we may not be able to remove your personal information, in which case we will let you know if we are unable to do so and why. If you would like to correct or update your personal information, you can manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard. If you would like to delete your account or remove your information from our Website and Services, send an e-mail to privacy@jdsupra.com.

We reserve the right to change this Privacy Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our Privacy Policy will become effective upon posting of the revised policy on the Website. By continuing to use our Website and Services following such changes, you will be deemed to have agreed to such changes.

If you have any questions about this Privacy Policy, the practices of this site, your dealings with our Website or Services, or if you would like to change any of the information you have provided to us, please contact us at: privacy@jdsupra.com.

As with many websites, JD Supra's website (located at http://www.jdsupra.com) (our "Website") and our services (such as our email article digests)(our "Services") use a standard technology called a "cookie" and other similar technologies (such as, pixels and web beacons), which are small data files that are transferred to your computer when you use our Website and Services. These technologies automatically identify your browser whenever you interact with our Website and Services.

We use cookies and other tracking technologies to:

There are different types of cookies and other technologies used our Website, notably:

JD Supra Cookies. We place our own cookies on your computer to track certain information about you while you are using our Website and Services. For example, we place a session cookie on your computer each time you visit our Website. We use these cookies to allow you to log-in to your subscriber account. In addition, through these cookies we are able to collect information about how you use the Website, including what browser you may be using, your IP address, and the URL address you came from upon visiting our Website and the URL you next visit (even if those URLs are not on our Website). We also utilize email web beacons to monitor whether our emails are being delivered and read. We also use these tools to help deliver reader analytics to our authors to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

Analytics/Performance Cookies. JD Supra also uses the following analytic tools to help us analyze the performance of our Website and Services as well as how visitors use our Website and Services:

Facebook, Twitter and other Social Network Cookies. Our content pages allow you to share content appearing on our Website and Services to your social media accounts through the "Like," "Tweet," or similar buttons displayed on such pages. To accomplish this Service, we embed code that such third party social networks provide and that we do not control. These buttons know that you are logged in to your social network account and therefore such social networks could also know that you are viewing the JD Supra Website.

If you would like to change how a browser uses cookies, including blocking or deleting cookies from the JD Supra Website and Services you can do so by changing the settings in your web browser. To control cookies, most browsers allow you to either accept or reject all cookies, only accept certain types of cookies, or prompt you every time a site wishes to save a cookie. It's also easy to delete cookies that are already saved on your device by a browser.

The processes for controlling and deleting cookies vary depending on which browser you use. To find out how to do so with a particular browser, you can use your browser's "Help" function or alternatively, you can visit http://www.aboutcookies.org which explains, step-by-step, how to control and delete cookies in most browsers.

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

If you have any questions about how we use cookies and other tracking technologies, please contact us at: privacy@jdsupra.com.

Follow this link:
Biopharma Develops Antibody and Stem Cell Therapies in the Fight Against COVID-19 - JD Supra

Bone Marrow Stem Cells Comments Off on Biopharma Develops Antibody and Stem Cell Therapies in the Fight Against COVID-19 – JD Supra | May 1st, 2020

Cryopreservation has become an indispensable step in the daily routine of scientific research as well as in a number of medical applications, ranging from assisted reproduction and transplantations to cell-based therapies and biomarker identification. It is hardly possible to picture todays scientific and medical advancements without this technique.The successful development and implementation of all the therapeutic and scientific discoveries involving cryopreservation relies on the correct and safe translation of the method from the laboratory to the clinical and manufacturing scale.

With the need to correctly use this technique, more research is focusing on optimizing cryopreservation methods and investigating what the long-term effects and consequences are on the physiology of the cryopreserved material.

An important part of cell therapy research is focused on adult stem cells (ASCs). ASCs can be derived from different sources such as peripheral blood, bone marrow or adipose tissue and display strong promises because of their capacity to differentiate into any cell type of the human body.In recent work3, the team of Michael Pepper at the Institute for Cellular and Molecular Medicine in Pretoria, South Africa, explored the effects of cryopreservation on the differentiation ability of adipose tissue-derived stem cells (ADSCs). After analyzing gene expression of key adipogenic genes and the degree of differentiating cells, characterized with high levels of CD36 and intracellular lipid droplets, the scientists reported that slow freeze cryopreservation of cells shortly after their isolation causes no alterations on their ability to differentiate. Pepper is convinced of the necessity to perform such analysis when cryopreserving important cell pools: It is critical to do a post-thaw analysis of cell function to determine how the cryopreservation may have affected the cells.His team is analyzing the effects of cryopreservation on other cell types largely used in cell-based therapies such as hematological stem cells and peripheral blood mononuclear cells (PBMCs). Although they didnt observe major alterations in terms of immunophenotyping or the post-thaw proliferation of the cells, Pepper expresses his concern that more subtle characteristics might be affected.

Correct cryopreservation of cells intended for therapeutic use is crucial. This is very important particularly as cells may persist for a long time in the recipient. This area of cell therapy research definitely requires more attention, Pepper says. Moreover, his words reflect on the need to evaluate not only the direct post-thaw recovery, but to look deeper into the late-onset effects cryopreservation might have and ensure that transplanted cells have preserved their therapeutic properties.

In contrast to slow freezing, vitrification relies on the fast freezing of the material by putting it in high concentration of cryoprotectant and in contact with liquid nitrogen. This method allows the direct transition of water from liquid to solid state without crystal formation. The highly concentrated cryoprotectant prevents ice formation and therefore there is no need for slow cooling.

Although vitrification has a great potential, there are a couple of parameters that are a point of concern. The quick and drastic freeze is possible thanks to the high concentration of cryoprotectant, but the latter is also associated with higher toxicity. In some cases, an additional limitation is the direct contact of the sample with liquid nitrogen which is a predisposition for viral or bacterial contamination.The team of Christiani Amorim at the Institute for Experimental and Clinical Research in Louvain, Belgium, is approaching the challenges of vitrification in the context of ovarian auto-transplantation. Ovarian auto-transplantation consists of preserving a piece of ovarian tissue with active follicles from the pre-therapeutic ovary of a cancer patient, as chemotherapy often has damaging effects on the reproductive organs. This tissue sample will be conserved and auto-transplanted onto the patients ovary when she has recovered and wishes to become pregnant.In their recent research4, the authors used stepped vitrification, in which the concentration of the cryoprotectant is gradually increased while simultaneously temperature decreases. This avoids ice crystal formation and also prevents cryoprotectant toxicity.Although stepped vitrification has previously given good results in bovine ovarian tissue5, this was not the case for human ovarian tissue. The scientists didnt detect normal follicles following thawing and linked this to high cryoprotectant toxicity. Indeed, they observed all signs of dimethyl sulfoxide (DMSO)-related cell membrane damage: significant organelle damage, cell membrane disintegration and apoptosis. These observations imply on the variability of outcomes that the method could give when applied to the same type of tissue but from a different organism.Amorim is positive about the future of their method and recognizes the need for further research on the topic: I can see a great potential in the stepped vitrification approach, but I also believe that there is a lot we still need to learn before thinking about using it as method of choice for human ovarian tissue cryopreservation. The high cryoprotectant concentration that should be applied in this approach is my first concern. () Our study clearly showed that 50% DMSO is too high, so we need to try lower concentrations or combine it with other cryoprotectants.

Read the rest here:
Freezing Life: The Current Trends in Cryopreservation - Technology Networks

Bone Marrow Stem Cells Comments Off on Freezing Life: The Current Trends in Cryopreservation – Technology Networks | May 1st, 2020

What is bone marrow cancer? Types, symptoms and treatment methods you must know  |  Photo Credit: Getty Images

New Delhi: Cancer is becoming a relatively very common disease, among people all around the world. It is a condition where abnormal cells divide uncontrollably in the body and destroy healthy body tissues as well. Cancer usually requires extensive treatment, and can also be life-threatening. Cancer accounted for 9.6 million deaths in 2018, according to WHO. Various popular personalities like Indian actors Irrfan Khan and Rishi Kapoor recently lost their lives to different types of cancer.

Rishi Kapoor was suffering from a bone marrow cancer, and breathed his last on Thursday morning, 30th of April. Here is what you need to know about bone marrow cancer, the cancer veteran actor was suffering from.

The bone marrow is a spongy tissue inside some of our bones. In humans, thesebones include the hips, thighs, etc. The bone marrow is the tissue where stem cells can develop into red blood cells, white blood cells, and platelets, all of which perform specific functions in the body.

Bone marrow cancer is a rare type of cancer. Bone marrow cancer happens when cells in the marrow start growing abnormally. It is a type of blood cancer and not bone cancer. Bone marrow cancer is the type that originates in the marrow and not the type that spreads to the bone or the marrow, after originating in some other part of the body.

Bone marrow cancer can be of various types, depending on the type of cells it affects -

Symptoms of bone marrow cancer vary, according to the type of cells that cancer affects. These include -

Multiple Myeloma Symptoms

Leukaemia symptoms

Lymphoma symptoms

Bone Marrow cancer can be treated by a medical professional. Chances of survival of the patient depend on the stage of cancer, how early the diagnosis is made, and other factors. Treatment methods include -

Disclaimer: Tips and suggestions mentioned in the article are for general information purposes only and should not be construed as professional medical advice. Always consult your doctor or a professional healthcare provider if you have any specific questions about any medical matter.

Read more from the original source:
What is bone marrow cancer? Leukaemia and other types, symptoms and treatment methods you must know - Times Now

Bone Marrow Stem Cells Comments Off on What is bone marrow cancer? Leukaemia and other types, symptoms and treatment methods you must know – Times Now | May 1st, 2020

Transforming old human cells into a youthful and vigorous state is what Regenerative Medicine is all about. Regenerative Therapy is a same-day nonsurgical procedure that involves working on cells and tissues either by replacing, engineering or growing them to establish normalcy. Contrary to surgeries, Regenerative Medicine gets to the root cause of the problem where stem cells communicate with the injured cells to initiate the healing process.

Stimulating the bodys mechanism to repair or heal tissues, regenerative therapy coaxes old human cells to express a panel of proteins involved in embryonic development. As cartilages, tendons, and nerves have limited healing capacity when compared to other parts of the body, regenerative therapies especially target these areas to treat common injuries, orthopedic problems or degenerative joint conditions.

Benefits of Regenerative Medicine

Regenerative medicines nullify the problem of reactions or infections. As it is a non-surgical procedure, it eliminates the pain and complications that occur otherwise. Enhancing healing and recovery, regenerative therapy is quick, long-lasting and mostly preferred by sportspersons. Biologic Products like PRP (platelet-rich plasma) and BMC (bone marrow concentrate) are actively developed for orthopedic procedures, enhancing usage potential and refinement.

PRP(Platelet Rich Plasma)

Focussed on patients platelets and blood cells, PRP releases concentrated proteins following implantation. The released proteins coordinate injured cells and stimulate healing.

BMC (Bone Marrow Concentrate)

Similar to PRP, BMC consists of several stem cells that have the potential to replace themselves as the original cells or can be used to release proteins and communicate with the injured cells to promote healing and repair.

Being an Ivy-trained physician and the founding CEO of Greyledge Technologies, Dr. Karlis medical practice integrates injection-based Regenerative Medicine and Cell Therapy techniques into a traditional non-operative orthopedic and sports medicine approach. Dr. David Karli develops biologic products in the regenerative medicine space. Earlier, degenerative joint problems were treated by blocking or inhibiting the bodys response to injury. Modernizing the traditional approach, Dr. Karli, at Greyledge Technologies prepares biologic products from a patients tissue and puts it back into the same patient. The human blood or bone marrow is processed as implantable materials.

During the biologic processing, he further collaborates with other medical faculty to develop and apply these products onto the injured tissues and stimulate healing. Dr. Karlis passion for regenerative medicine and the evolution of non-surgical procedures for various health problems helped him to develop Platelet Rich Plasma (PRP) and BMC(Bone Marrow Concentrate). The two stem cell injection therapy procedures cure acute and chronic musculoskeletal injuries.

See the original post here:
Familiarizing non-surgical Orthopaedic Treatments with Dr. David Karli - The American Reporter

Bone Marrow Stem Cells Comments Off on Familiarizing non-surgical Orthopaedic Treatments with Dr. David Karli – The American Reporter | May 1st, 2020

Now that your makeup layer is gone, you can proceed with washing your face. "A cleanser gets rid of dead skin, pollutants, oils, dirt, and bacteria," says Rabach. Both she and Ciraldo recommend also doing this step when you first wake up in the morning, in order to prep your skin to absorb the active ingredients in your other products.

The best cleanser for you will depend on your skin type. "It's important to pay attention to what's in your cleanser and what's not in it," says Ciraldo. She recommends avoiding sulfates, which can have a harsh, stripping effect on your faceand looking for actives that suit your needs. "For normal or dry skin, I favor a hydrating cleanser with peptides," she says. "If you're oily or acne-prone, use a mild exfoliating cleanser with salicylic acid, which dislodges the dead cells that can clog pores."

Do This Step: Morning and Night

The first product to go on your face? Eye cream. The reason is simplebecause you'll probably forget to do it otherwise. Ciraldo recommends patting eye cream on gently with your ring finger (this way you'll tug less at the delicate skin there) all the way around your eyes, not just underneath them. If you're worried about eye cream causing your concealer or eye makeup to smear, choose a more lightweight option, like a hydrating gel that sinks in quickly and stays put.

For the best results, look for ingredients like peptideswhich help tighten your skin and de-puffas well as antioxidants. Rabach recommends formulas that contain hydrating hyaluronic acid, brightening caffeine, and ceramides (these lock in moisture and help strengthen your skin barrier).

Do This Step: Morning and Night

Both toners and essences are meant to help further prime your skin to absorb active ingredients, but the one you choose will depend on your skin type. Old-school toners were meant to balance skin pH and counteract alkaline soaps, before soap-free cleansers became popular. Now, toner usually refers to liquid formulations geared toward oily skin that's in need of gentle exfoliation and resurfacing. Ciraldo says those with oily or acne-prone skin should look for toners with ingredients like glycolic or salicylic acid.

Essences, on the other hand, tend to be more hydrating. Rabach recommends looking for actives like hyaluronic acid, which will flood your skin with moisture that you can lock in during subsequent steps. To apply, soak a cotton pad in liquid and gently pat it over your face. Alternatively, you can use your hands to do the same thing.

Do This Step: Morning and Night

This is the step where you'll deliver the bulk of active ingredients to your toner/essence-primed face, and it's important to do it early on in your routine. "Serums are formulated with smaller molecular-weight actives so they penetrate into deeper skin layers," says Ciraldo. "If you apply your serum after a thicker formulation, the active ingredients may not penetrate as well."

While you should apply serum twice a day, you shouldn't be using the same formulation. "Serum actives differ for day and night," says Rabach. During the day, she likes to choose serums with antioxidants that protect skin from daytime stressors like free radicals (caused by UV rays), pollutants, and blue light. The most popular ingredient for this is vitamin C, which you will have no problem finding in serum form. (Just make sure to choose one that's properly stabilized for maximum effect.) At night, opt for a serum with peptides and growth factors to repair skin.

For both daytime and nighttime serums, Rabach also has a general list of ingredients she likes to look for across both formulations: Niacinamide to reduce redness, hyaluronic acid to pull moisture into your skin, and alpha and beta hydroxy acids (AHAs and BHAs), which help boost collagen and even out skin pigmentation. Ciraldo further splits up her preferred serum ingredients by skin type. "For acne-prone skin, look for stem cells, retinol, and green tea," she says. "For dehydrated skin, look for lipids, hyaluronic acid, and peptides. And for hyperpigmented skin, look for vitamin C."

Do This Step: At Night Only

Read more from the original source:
Best Skin Care Routine: Order of Products to Use Morning & Night - Glamour

Skin Stem Cells Comments Off on Best Skin Care Routine: Order of Products to Use Morning & Night – Glamour | May 1st, 2020

The GlobalProgenitor Cell Product Market2020 report implement in-depth research of the industry with a focus on the current market trends future prospects. The Global Progenitor Cell Product Market report aims to provide an overview of Progenitor Cell Product Market players with detailed market segmentation by product, application and geographical region. It also provides market share and size, revenue forecast, growth opportunity. The most recent trending report Worldwide Progenitor Cell Product Market Economy by Manufacturers, Regions, kind and application, forecast to 2025 provided bySupply demand Market Researchis an educational study covering the marketplace with detailed analysis.

All the reports consider COVID-19 impact for forecast and analysis.

Feel free to contact us for any inquiry, Get Free PDF Sample Copy of Progenitor Cell Product Market @https://www.supplydemandmarketresearch.com/home/contact/972493?ref=Sample-and-Brochure&toccode=SDMRPH972493

The analysis of Global Progenitor Cell Product Market includes market size, upstream situation, market segmentation, price & cost and industry environment. In addition, the report outlines the factors driving industry growth and the description of market channels. The report begins from overview of industrial chain structure, and describes the upstream. Besides, the report analyses market size and forecast in different geographies, type and end-use segment, in addition, the report introduces market competition overview among the major companies and companies profiles, besides, market price and channel features are covered in the report.

This report studies the Progenitor Cell Product Market status and outlook of Global and major regions, from angles of players, countries, product types and end industries; this report analyzes the top players in global market, and splits the Progenitor Cell Product Market by product type and applications/end industries. These details further contain a basic summary of the company, merchant profile, and the product range of the company in question. The report analyzes data regarding the proceeds accrued, product sales, gross margins, price patterns, and news updates relating to the company.

Global Progenitor Cell Product Market Type (Pancreatic progenitor cells, Cardiac Progenitor Cells, Intermediate progenitor cells, Neural progenitor cells (NPCs), Endothelial progenitor cells (EPC), Others) Application (Medical care, Hospital, Laboratory) Global Trends and Forecasts to 2025

Industry Insights

The Global Progenitor Cell Product Market is expected to grow at a CAGR of XX % during the forecast period 2018-2025.

The Global Progenitor Cell Product Market is segmented on the basis of Type and Application. The Global Progenitor Cell Product Market is segmented based on the basis of typePancreatic progenitor cells, Cardiac Progenitor Cells, Intermediate progenitor cells, Neural progenitor cells (NPCs), Endothelial progenitor cells (EPC), Others. By Application, it is classified as Medical care, Hospital, Laboratory. The regional outlook on the Global Progenitor Cell Product Market covers regions, such as North America, Europe, Asia-Pacific, and Rest of the World. Global Progenitor Cell Product Market for each region is further bifurcated for major countries including the U.S., Canada, Germany, the U.K., France, Italy, China, India, Japan, Brazil, South Africa, and others.

Report Scope:

The Global Progenitor Cell Product Market report scope covers the in-depth business analysis considering major market dynamics, forecast parameters, and price trends for the industry growth. The report forecasts market sizing at global, regional and country levels, providing comprehensive outlook of industry trends in each market segments and sub-segments from 2017 to 2024. The market segmentations include

GlobalProgenitor Cell Product Market, By Type

Pancreatic progenitor cells, Cardiac Progenitor Cells, Intermediate progenitor cells, Neural progenitor cells (NPCs), Endothelial progenitor cells (EPC), Others

In the same way, the study has divided by applications

Global Progenitor Cell Product Market, By Application

Medical care, Hospital, Laboratory

GlobalProgenitor Cell Product Market, By Region

The report scope also includes competitive landscape covering the competitive analysis, strategy analysis and company profiles of the major market players. The companies profiled in the report includeNeuroNova AB, StemCells, ReNeuron Limited, Asterias Biotherapeutics, Thermo Fisher Scientific, STEMCELL Technologies, Axol Bio, R&D Systems, Lonza, ATCC, Irvine Scientific, CDI

Report Highlights

How this report will add value to your organisation

This report provides the in-depth analysis of the complete value chain from the raw material suppliers to the end users. We have critically analysed following parameters and their impact in the industry:

1. Improvement in top line and bottom line growth

Analysis trend & forecasts by end use markets will help you to understand how the growth in consumption is expected in next 5 years and what will be the key factors that will support the growth. This will help to make a clear plan for the top line growth. Price analytics will also play a crucial role in making a plan for top line growth.

Raw material and other input factors analysis will help to plan effectively for the bottom line.

2. Competitive intelligence

In a competitive marketplace, up-to-date information can make the difference between keeping pace, getting ahead, or being left behind. A smart intelligence operation can serve as an early-warning system for disruptive changes in the competitive landscape, whether that change is a rivals new product or pricing strategy or the entrance of an unexpected player into your market.

We also provide you with information that allows you to anticipate what your competitors are planning next. For example, you might gain information on a new product they are getting ready to launch or new services they will add to the business. Hiring us to handle this information collection saves you time and energy, allowing you to focus on your own business while still gaining the necessary knowledge to keep track of competitors.

3. Identification of prospective customers and their satisfaction level with the current supplier:

We have provided the long list of customers and analysed them critically, based on various parameters such as consumption, market type, sustainable business etc. this will help your organisation to develop relations with the consumers. Also, we have identified the factors in which the others customer will switch to you.

Report Customizations

The customization research services cover the additional custom report features such as additional regional and country level analysis as per the client requirements.

Get More Information About Full Report Progenitor Cell Product Market @https://www.supplydemandmarketresearch.com/home/contact/972493?ref=Discount&toccode=SDMRPH972493

This comprehensive report can be a guideline for the industry stakeholders that helps in analyzing the Progenitor Cell Product Market and forecast of till 2024. This report aids to detection of the projected market size, market status, future predictions, growth prospect, main challenges of Progenitor Cell Product Market by analyzing the segmentations.

In the following section, the report provides the Progenitor Cell Product Market company outline, statements of the product, and performance values. With the support of the arithmetical study, the report demonstrates the complete international Progenitor Cell Product Market market inclusive of amplitude, production, manufacturing value, loss/gain, Progenitor Cell Product Market supply/demand and import/export. The Progenitor Cell Product Market report is divided into key companies, by regions, and by various sectors such as application, type for the competitive landscape analyze.

Analysis of various Progenitor Cell Product Market categories of product and end-user applications, product types of Progenitor Cell Product Market is estimated on the basis of previous market and present market scenario. It involved Global Progenitor Cell Product Market values with respect to growth rate, market size, and share and consumption. Further, it gives details, prerequisite, and features of Progenitor Cell Product Market that boost the growth of the industry.

About Us:

We have a strong network of high powered and experienced global consultants who have about 10+ years of experience in the specific industry to deliver quality research and analysis. Having such an experienced network, our services not only cater to the client who wants the basic reference of market numbers and related high growth areas in the demand side, but also we provide detailed and granular information using which the client can definitely plan the strategies with respect to both supply and demand side.

Contact Us:

Nimesh H

302-20 Misssisauga, Valley, Missisauga,

L5A 3S1, Toronto, Canada

Phone Number: +1-276-477-5910

Email- [emailprotected]

See the original post here:
Progenitor Cell Product Market 2020 Recent Industry Developments and Growth Strategies Adopted by Top Key Players Worldwide and Assessment to 2025 ...

Cardiac Stem Cells Comments Off on Progenitor Cell Product Market 2020 Recent Industry Developments and Growth Strategies Adopted by Top Key Players Worldwide and Assessment to 2025 … | May 1st, 2020

The healthcare industry has been focusing on excessive research and development in the last couple of decades to ensure that the need to address issues related to the availability of drugs and treatments for certain chronic diseases is effectively met. Healthcare researchers and scientists at the Li Ka Shing Faculty of Medicine of the Hong Kong University have successfully demonstrated the utilization of human induced pluripotent stem cells or hiPSCs from the skin cells of the patient for testing therapeutic drugs.

The success of this research suggests that scientists have crossed one more hurdle towards using stem cells in precision medicine for the treatment of patients suffering from sporadic hereditary diseases. iPSCs are the new generation approach towards the prevention and treatment of diseases that takes into account patients on an individual basis considering their genetic makeup, lifestyle, and environment. Along with the capacity to transform into different body cell types and same genetic composition of the donors, hiPSCs have surfaced as a promising cell source to screen and test drugs.

Report Highlights:

Get Sample Copy of Report @ https://www.persistencemarketresearch.com/samples/17968

Company Profile

Get To Know Methodology of Report @ https://www.persistencemarketresearch.com/methodology/17968

In the present research, hiPSC was synthesized from patients suffering from a rare form of hereditary cardiomyopathy owing to the mutations in Lamin A/C related cardiomyopathy in their distinct families. The affected individuals suffer from sudden death, stroke, and heart failure at a very young age. As on date, there is no exact treatment available for this condition.

This team in Hong Kong tested a drug named PTC124 to suppress specific genetic mutations in other genetic diseases into the iPSC transformed heart muscle cells. While this technology is being considered as a breakthrough in clinical stem cell research, the team at Hong Kong University is collaborating with drug companies regarding its clinical application.

The unique properties of iPS cells provides extensive potential to several biopharmaceutical applications. iPSCs are also used in toxicology testing, high throughput, disease modeling, and target identification. This type of stem cell has the potential to transform drug discovery by offering physiologically relevant cells for tool discovery, compound identification, and target validation.

A new report by Persistence Market Research (PMR) states that the globalinduced pluripotent stem or iPS cell marketis expected to witness a strong CAGR of 7.0% from 2018 to 2026. In 2017, the market was worth US$ 1,254.0 Mn and is expected to reach US$ 2,299.5 Mn by the end of the forecast period in 2026.

Access Full Report @ https://www.persistencemarketresearch.com/checkout/17968

Customization to be the Key Focus of Market Players

Due to the evolving needs of the research community, the demand for specialized cell lines have increased to a certain point where most vendors offering these products cannot depend solely on sales from catalog products. The quality of the products and lead time can determine the choices while requesting custom solutions at the same time. Companies usually focus on establishing a strong distribution network for enabling products to reach customers from the manufacturing units in a short time period.

Entry of Multiple Small Players to be Witnessed in the Coming Years

Several leading players have their presence in the global market; however, many specialized products and services are provided by small and regional vendors. By targeting their marketing strategies towards research institutes and small biotechnology companies, these new players have swiftly established their presence in the market.

Link:
Induced Pluripotent Stem Cells Market to Witness CAGR 8.7% Growth in Revenue During the Period 2026 - Cole of Duty

Skin Stem Cells Comments Off on Induced Pluripotent Stem Cells Market to Witness CAGR 8.7% Growth in Revenue During the Period 2026 – Cole of Duty | April 30th, 2020

Transparency Market Research (TMR)has published a new report on theamniotic membrane marketfor the forecast period of2019-2027. According to the report, the global amniotic membrane market was valued at ~US$ 980 Mnin2018and is projected to expand at a CAGR of ~10%from2019to2027.

GlobalAmniotic Membrane Market:Overview

Request for Brochure of Report - https://www.transparencymarketresearch.com/sample/sample.php?flag=B&rep_id=42059

Increase in Research on Stem Cell Biology & Regenerative Medicineto Drive Market

Cryopreserved Amniotic Membrane Products to Dominate Market

Request for Analysis of the COVID19 Impact on Amniotic Membrane Market - https://www.transparencymarketresearch.com/sample/sample.php?flag=covid19&rep_id=42059

Ophthalmology to be Promising Application

Hospitals Account for Major Share of Global Market

North America to Dominate Global Amniotic Membrane Market

Request for Custom Research - https://www.transparencymarketresearch.com/sample/sample.php?flag=CR&rep_id=42059

Global Amniotic Membrane Market: Competitive Landscape

About Us

Transparency Market Research is a next-generation market intelligence provider, offering fact-based solutions to business leaders, consultants, and strategy professionals.

Our reports are single-point solutions for businesses to grow, evolve, and mature. Our real-time data collection methods along with ability to track more than one million high growth niche products are aligned with your aims. The detailed and proprietary statistical models used by our analysts offer insights for making right decision in the shortest span of time. For organizations that require specific but comprehensive information we offer customized solutions through ad hoc reports. These requests are delivered with the perfect combination of right sense of fact-oriented problem solving methodologies and leveraging existing data repositories.

TMR believes that unison of solutions for clients-specific problems with right methodology of research is the key to help enterprises reach right decision.

Contact

Transparency Market ResearchState Tower,90 State Street,Suite 700Albany NY - 12207United StatesUSA - Canada Toll Free: 866-552-3453Email:sales@transparencymarketresearch.comWebsite:https://www.transparencymarketresearch.com

Originally posted here:
Amniotic Membrane Market: Locally Available Amniotic Allografts Increasingly Meeting Needs of Patients with Joint Pain - BioSpace

Skin Stem Cells Comments Off on Amniotic Membrane Market: Locally Available Amniotic Allografts Increasingly Meeting Needs of Patients with Joint Pain – BioSpace | April 30th, 2020

Home Topics Lung Infection

Mesoblast announced data from a phase 2/3 trial evaluating remestemcel-L, an allogeneic mesenchymal stem cell product candidate, in ventilator-dependent COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS).

Remestemcel-L consists of culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. It is believed to work by down-regulating the production of proinflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.

The randomized, placebo-controlled trial is being conducted at Mount Sinai hospital in New York City. Patients were treated with a variety of experimental agents prior to receiving remestemcel-L. Findings from the study showed 83% survival in ventilator-dependent COVID-19 patients with moderate/severe ARDS (n=10/12) following 2 intravenous infusions of remestemcel-L within the first 5 days; 75% of patients (n=9/12) were able to successfully come off ventilator support at a median of 10 days. There have been 7 patients discharged from the hospital as of now.

Mesoblast Chief Executive Dr. Silviu Itescu stated: The remarkable clinical outcomes in these critically ill patients continue to underscore the potential benefits of remestemcel-L as an anti-inflammatory agent in cytokine release syndromes associated with high mortality, including acute graft versus host disease and COVID-19 ARDS. We intend to rapidly complete the randomized, placebo-controlled phase 2/3 trial in COVID-19 ARDS patients to rigorously confirm that remestemcel-L improves survival in these critically ill patients.

Additionally, the Food and Drug Administration recently accepted for Priority Review the Biologics License Application of remestemcel-L for the treatment of steroid-refractory acute graft vs host disease. The Company expects to launch remestemcel-L in 2020 if approved.

For more information mesoblast.com.

This article originally appeared on MPR

Please login or register first to view this content.

LoginRegister

Next post in Lung InfectionClose

Continue reading here:
Remestemcel-L Looks Promising for COVID-19 With Moderate to Severe ARDS - Pulmonology Advisor

Bone Marrow Stem Cells Comments Off on Remestemcel-L Looks Promising for COVID-19 With Moderate to Severe ARDS – Pulmonology Advisor | April 30th, 2020

Thefirst-in-human, universal chimeric receptor antigen (CAR) T-cell (CAR-T)therapy GC027 was tolerable and resulted in antileukemic responses amongpatients with relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL),according to results from a phase 1 trial presented at the American Associationfor Cancer Research (AACR) Virtual Annual Meeting I 2020.1

The universal CAR T cells target CD7, which, according to Xinxin Wang, PhD, of Gracell Biotechnologies Co, Ltd, in China, and lead author and presenter of the study, is a good target for T-ALL because it is expressed by more than 95% of T-ALL patients.

GC027 isallogeneic, which may prevent the development of graft-versus-host disease. Theproduct is introduced using lentivirus for rapid elimination of T-ALL cells. Preclinicalstudies showed efficacy in a T-ALL xenograft model, and this prospective studyevaluated the safety and efficacy in humans.

Thesingle-arm, open-label study treated 5 adult patients with relapsed/refractoryCD7-positive T-ALL with a single infusion of 1 of 3 different dose levels ofG027: 0.6 x 107/kg, 3 x 107/kg, and 1.5 x 107/kg.Lymphodepletion therapy was administered prior to the G027 infusion. Theprimary endpoint was safety and the secondary endpoints included objectiveresponse rate (ORR) within 3 months after G027 infusion.

Patients with extramedullary or central nervous system disease were excluded. At baseline, the median age was 24 (range, 19-38). Patients were heavily pretreated, with 5 median number of prior therapies (range, 1-9). Two patients had high-risk disease and the median bone marrow tumor burden was a median of 38.2% of blasts. None of the patients had undergone a prior allogeneic hematopoietic stem cell transplant.

Allpatients developed cytokine release syndrome (CRS), 4 of which were grade 3 and1 was grade 4. All cases were manageable and resolved with treatment andsupportive care. None of the patients developed neurotoxicity.

The completeremission (CR)/CR with incomplete hematologic recovery was 100%. By day 28, 4patients achieved a CR with negative for minimal residual disease (MRD) and 3of these patients remained MRD negative up to day 161. One patient achieved CRbut was MRD positive, and relapsed by day 29.

Peak CART-cell expansion in peripheral blood occurred between week 1 and 2.

As the first-in-human, universal CAR T-cell therapy for adult relapsed/refractory T-ALL, Dr Wang said, GC027 has demonstrated superior clinical efficacy and induced deep response in patients with acceptable safety profile. She added that trial enrollment is ongoing.

Reference

Wang X, Li S, Gao L, et al. Clinical safety and efficacy study of TruUCAR GC027: The first-in-human, universal CAR-T therapy for adult relapsed/refractory T-cell acute lymphoblastic leukemia (r/r T-ALL). Presented at: American Association for Cancer Research (AACR) Virtual Annual Meeting I; April 27-28, 2020. Abstract CT052.

This article originally appeared on Cancer Therapy Advisor

More here:
First-in-Human Universal CAR-T Therapy Found Active in Relapsed/Refractory T-ALL - Hematology Advisor

Bone Marrow Stem Cells Comments Off on First-in-Human Universal CAR-T Therapy Found Active in Relapsed/Refractory T-ALL – Hematology Advisor | April 30th, 2020

BACKGROUND:

Osteoporosisis a metabolic bone disease characterized by low bone density resulting in increased fracture susceptibility. This research was constructed to uncover the potential therapeutic application of osteoblasts transplantation, generated upon culturing male rat bone marrow-derived mesenchymal stem cells (BM-MSCs) in osteogenic medium (OM), OM containing gold (Au-NPs) or gold/hydroxyapatite (Au/HA-NPs) nanoparticles, in ovariectomized rats to counteractosteoporosis.

Forty rats were randomized into: (1) negative control, (2) osteoporotic rats, whereas groups (3), (4) and (5) constituted osteoporotic rats treated with osteoblasts yielded from culturing BM-MSCs in OM, OM plus Au-NPs or Au/HA-NPs, respectively. After 3months, osterix (OSX), bone alkaline phosphatase (BALP), sclerostin (SOST) and bone sialoprotein (BSP) serum levels were assessed. In addition, gene expression levels of cathepsin K, receptor activator of nuclear factor-b ligand (RANKL), osteoprotegerin (OPG) and RANKL/OPG ratio were evaluated using real-time PCR. Moreover, histological investigation of femur bone tissues in different groups was performed. The homing of implanted osteoblasts to the osteoporotic femur bone of rats was documented by Sex determining region Y gene detection in bone tissue.

Our results indicated that osteoblasts infusion significantly blunted serum BALP, BSP and SOST levels, while significantly elevated OSX level. Also, they brought about significant down-regulation in gene expression levels of cathepsin K, RANKL and RANKL/OPG ratio versus untreated osteoporotic rats. Additionally, osteoblasts nidation could restore bone histoarchitecture.

These findings offer scientific evidence that transplanting osteoblasts in osteoporotic rats regains the homeostasis of the bone remodeling cycle, thus providing a promising treatment strategy for primaryosteoporosis.

The rest is here:
Osteoblast-Based Therapy-A New Approach for Bone Repair in Osteoporosis: Pre-Clinical Setting - DocWire News

Bone Marrow Stem Cells Comments Off on Osteoblast-Based Therapy-A New Approach for Bone Repair in Osteoporosis: Pre-Clinical Setting – DocWire News | April 30th, 2020

This Placental Stem Cells (PSCS) industry report provides comprehensive analysis as follows Market segments and sub-segments, Market size, Market trends and flow, Major Manufacturers Production and Sales Market Comparison Analysis, Drivers and Opportunities, Competitive scene, Product Specification and Major Types Analysis, Supply and demand, Regional Production Market Analysis, Regional Market Performance and Market Share. The Placental Stem Cells (PSCS) market research report covers effectiveness and summary of the marketing research. These results can be employed to make improvements in the business. The report helps to save a large amount of time and money that may get spend on marketing.

Get ExclusiveSample Copy of This Report Herehttps://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-placental-stem-cells-pscs-market

Placentalstem cells(PSCS) market is expected to gain market growth in the forecast period of 2020 to 2027. Data Bridge Market Research analyses the market to growing at a CAGR of 10.25% in the above-mentioned forecast period. Increasing awareness regarding the benefits associates with the preservation of placental derived stem cells will boost the growth of the market.

The major players covered in theplacental stem cells (PSCS) marketreport areCBR Systems, Inc, Cordlife India, Cryo-Cell International, Inc., ESPERITE N.V., LifeCell International Pvt. Ltd., StemCyte India Therapeutics Pvt. Ltd, PerkinElmer Inc, Global Cord Blood Corporation., Smart Cells International Ltd., Vita 34, among other domestic and global players. Market share data is available for Global, North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA) and South America separately.DBMR analysts understand competitive strengths and provide competitive analysis for each competitor separately.

Market Analysis and Insights of Global Placental Stem Cells (PSCS) Market

Adoption of advances and novel technologies that will lead to the storage and preservation of stem cells, technological advancement in the field of biotechnology, introduction of hematopoietic stem cell transplantation system and growing number of diseases which will helps in accelerating the growth of the placental stem cells (PSCS) market in the forecast period of 2020-2027. Surging number of applications from emerging economies along with rising awareness among the people will further boost many opportunities that will led to the growth of the placental stem cells (PSCS) market in the above mentioned forecast period.

Increasing operation costs along with stringent regulatory framework will likely to hamper the growth of the placental stem cells (PSCS) market in the above mentioned forecast period. Social and ethical issues will be the biggest challenge in the growth of the market.

Thisplacental stem cells(PSCS) market report provides details of new recent developments, trade regulations, import export analysis, production analysis, value chain optimization, market share, impact of domestic and localised market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on placental stem cells (PSCS) market contactData Bridge Market Researchfor anAnalyst Brief, our team will help you take an informed market decision to achieve market growth.

Read Complete Details with TOC Herehttps://www.databridgemarketresearch.com/toc/?dbmr=global-placental-stem-cells-pscs-market

Global Placental Stem Cells (PSCS) Market Scope and Market Size

Placental stemcells(PSCS) market is segmented on the basis of service type and application. The growth amongst these segments will help you analyse meagre growth segments in the industries, and provide the users with valuable market overview and market insights to help them in making strategic decisions for identification of core market applications.

Placental Stem Cells (PSCS) Market Country Level Analysis

Placental stemcells(PSCS) market is analysed and market size insights and trends are provided by country, service type and application as referenced above.

The countries covered in the placental stem cells (PSCS) market report are U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America.

North America dominates the bone marrow-derived stem cells (BMSCS) market due to the increasing stem cell procedure along with preferences of private stem cell banking over public and surging network of stem cell banking services.

The country section of the placental stem cells (PSCS) market report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as consumption volumes, production sites and volumes, import export analysis, price trend analysis, cost of raw materials, down-stream and upstream value chain analysis are some of the major pointers used to forecast the market scenario for individual countries. Also, presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.

Healthcare Infrastructure growth Installed base and New Technology Penetration

Placental stem cells (PSCS) market also provides you with detailed market analysis for every country growth in healthcare expenditure for capital equipments, installed base of different kind of products for placental stem cells (PSCS) market, impact of technology using life line curves and changes in healthcare regulatory scenarios and their impact on the placental stem cells (PSCS) market. The data is available for historic period 2010 to 2018.

Competitive Landscape and Placental Stem Cells (PSCS) Market Share Analysis

Placental stem cells (PSCS) market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies focus related to placental stem cells (PSCS) market.

To Get This Report at an Attractive Cost, Click Herehttps://www.databridgemarketresearch.com/inquire-before-buying/?dbmr=global-placental-stem-cells-pscs-market

About Data Bridge Market Research:

Data Bridge Market Researchis a versatile market research and consulting firm with over 500 analysts working in different industries. We have catered more than 40% of the fortune 500 companies globally and have a network of more than 5000+ clientele around the globe. Our coverage of industries include Medical Devices, Pharmaceuticals, Biotechnology, Semiconductors, Machinery, Information and Communication Technology, Automobiles and Automotive, Chemical and Material, Packaging, Food and Beverages, Cosmetics, Specialty Chemicals, Fast Moving Consumer Goods, Robotics, among many others.

Data Bridge adepts in creating satisfied clients who reckon upon our services and rely on our hard work with certitude.We are content with our glorious 99.9 % client satisfying rate.

Contact Us

Data Bridge Market Research

US: +1 888 387 2818

UK: +44 208 089 1725

Hong Kong: +852 8192 7475Mail:Corporatesales@databridgemarketresearch.com

See original here:
Placental Stem Cells (PSCS) Market is Prospering With Healthy CAGR in 2020. Leading Players are Cryo-Cell International, Inc., ESPERITE NV, LifeCell...

Bone Marrow Stem Cells Comments Off on Placental Stem Cells (PSCS) Market is Prospering With Healthy CAGR in 2020. Leading Players are Cryo-Cell International, Inc., ESPERITE NV, LifeCell… | April 30th, 2020

VANCOUVER, Washington, April 30, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced updates on 49 COVID-19 patients who have received leronlimab under the U.S. Food and Drug Administration's (FDA) emergency Investigational New Drug (eIND) program:

Eleven (11) Patients in NY hospital: All treated patients were in Intensive Care Units (ICU) because of acute respiratory failure, eight of whom were intubated (placed on mechanical ventilation). One patient was not intubated because of poor baseline pulmonary status (history of lung cancer and had undergone bilateral upper lobectomy). Seven patients were organ-transplant recipients (six patients were renal-transplant recipients and one patient had a history of heart transplant) and were on immunosuppressive regimen. Ten patients were on dialysis and nine were on vasopressors during hospitalization. Despite their pre-existing and severe conditions, we believe we were able to save the lives of four patients. All patient blood samples were evaluated and important powerful results from the effect of leronlimab were demonstrated in almost all of these patients. This data has been submitted to a prestigious journal and we expect the publication on Friday, May 1.

Twenty-three (23) patients in Southern California hospital: Six patients were in critical condition (intubated) and 17 patients were severely-ill, needing oxygen support. No death was reported. Out of 6 critical patients, all were intubated patients, 3 were extubated (taken off ventilator), 2 patients remain relatively stable and still breathing with the assistance of a ventilator and one patient has shown deterioration in respiratory parameters. Of 17 severe condition (but not critical) patients, 11 patients demonstrated improvement in respiratory parameters (8 of them were discharged from hospital, including one patient in the news, Samantha Mottet), 2 patients remain relatively stable, 2 have shown deterioration in respiratory parameters and information is pending for 2 recently treated patients.

Three (3) patients in Georgia hospital: All three ICU patients were intubated and two of them had renal failure at the start of leronlimab treatment. Of these 3 patients, 2 were extubated (taken off ventilator) and 1 patient remains on a ventilator but improving.

One (1) patient in another NY hospital: Patient was taken off oxygen and discharged from hospital after leronlimab treatment.

One (1) patient in Northern California hospital: Patient is now weaning from ventilator and transferred to rehabilitation hospital.

Updates are pending for 10 other patients. Five additional patients have been approved to receive leronlimab under eINDs, which increases the total eINDs approved by the FDA to 54 patients.

Bruce Patterson, M.D., Chief Executive Officer and founder of IncellDx, a diagnostics company and an advisor to CytoDyn, expanded on these findings by stating, "We are excited that patients are responding extremely well to leronlimab as expected from the novel mechanism of COVID-19 pathogenesis we discovered and will be reporting in the coming days."

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn said, "We believe these results, although anecdotal, are very impressive and the number of patients treated under eIND is rapidly increasing. The enrollment for our Phase 2 double-blind and Phase 2b/3 trials is moving along rapidly and we believe the results from both studies will be very powerful due to the mechanism of action (MOA) of affecting the viral load and restoring the immune system. With our first major paper very close to publication, we expect to have a second paper published shortly thereafter, as our MOA is as unique as our results."

About Coronavirus Disease 2019CytoDyn is currently enrolling patients in two clinical trials for COVID-19, a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.

SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140) The FDA has granted a "Fast Track" designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting aPhase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted "orphan drug" designation to leronlimab for the prevention of GvHD.

About CytoDynCytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells.The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn completed the filing of its BLA in April 2020 to seek FDA approval for leronlimab as a combination therapy for highly treatment experienced HIV patients. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.

Forward-Looking StatementsThis press releasecontains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as "believes," "hopes," "intends," "estimates," "expects," "projects," "plans," "anticipates" and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Company's forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Company's cash position, (ii)the Company's ability to raise additional capital to fund its operations, (iii) the Company's ability to meet its debt obligations, if any, (iv)the Company's ability to enter into partnership or licensing arrangements with third parties, (v)the Company's ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Company's ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Company's clinical trials, (viii)the results of the Company's clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company's products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Company's control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Dave Gentry, CEORedChip CompaniesOffice: 1.800.RED.CHIP (733.2447)Cell: 407.491.4498dave@redchip.com

See more here:
CytoDyn Reports Strong Results from eIND COVID-19 Patients Treated with Leronlimab; Majority of Patients Have Demonstrated Remarkable Recoveries -...

Bone Marrow Stem Cells Comments Off on CytoDyn Reports Strong Results from eIND COVID-19 Patients Treated with Leronlimab; Majority of Patients Have Demonstrated Remarkable Recoveries -… | April 30th, 2020

India with its huge population can become an ideal place for medical research in stem cell, but due to lack of awareness and investment, its progress is slowing down. Vipul Jain, CEO, Advancells talks about the companys vision for stem cell research and progress in India, to Usha Sharma

Give us a brief about your companys inception?

I have been a part of healthcare marketing for over 12 years now and somewhere in 2009-10, a few patients started talking about stem cell therapies if I could help them find a centre, where they could opt for these therapies. Unfortunately, none such centre operated in India and there were very few across the world. Once I studied the subject in-depth it occurred to me that this would be the future of medicine and it was the right time to enter this field. The hope of changing medicine as we know it today inspired me to get into this practice and I established Advancells in 2013.

In the past seven years of our operations, we have grown strength to strength and are today one of the largest providers of stem cell therapies in India.

When we started Advancells, we aimed at becoming a pioneer in the research and development of regenerative medicine. We wanted to have India at the forefront of protocols and technologies in the industry and so we decided to venture into a wide array of services. In order to become a centre of medical advancement, we had to ensure we offered services to all sorts of patients, irrespective of their condition. We believe in treating our patients in a progressive manner.

Tell us about the challenges you faced while setting up your business?

Lack of investment is the biggest challenge. Most new investments in healthcare sector still come from Trusts and charities who enter the segment for charity and with a no-profit no-loss mindset. This restrains their capacity to invest in research and new technologies and hence it is not easy to get cutting edge technologies in the country. India with its huge population base can be a perfect place for strong medical research but the lack of awareness and investment are the major reasons for India to lag behind in research. It is not easy for healthcare researchers to attract private money as private investors are worried about the long gestation period for their investment.

The other major challenge is the acceptance of doctors of a new branch of medicine. It is very difficult to convince doctors of a new way to treat patients and understandably they want long term follow-up data. This data will take time to come and hence growth can not be as fast as you expect it to be. Government regulations are another challenge as agencies are always a little slow to react to innovation.

The expense of research and clinical preliminaries is high in the case of regenerative medicine, in this way confining the research objectives. Aside from cost/enormous speculations, other challenges are administrative difficulties with changing rules across nations, on account of contrasts in the suppositions and social perspectives. Setting up a solitary/regular arrangement or rule worldwide to administer stem cell research could be helpful. Human embryos for research, somatic cell, nuclear move, IPSCs have raised concerns due to their long hatching periods.

So how does your model work?

Advancells works in four different verticals. Firstly, we produce basic human stem cells that are used by partner hospitals and doctors in providing regenerative therapies to the patients. Advancells also writes protocols for therapies and provide training to doctors on various facets of regenerative medicine. In the second vertical, we produce organ, species and disease-specific primary cells, which are used by research institutes, academic institutes and pharma companies around the world to further their research in the field of biology and drugs.

In the third vertical, we produce our patented range of bioscaffolds which once seeded with our cells, are used in the regeneration of bones, organs and healing of wounds. Fourthly, we print 3D human organs and finally seed our scaffolds with our primary cells and paste them on the 3D printed organ models and try to create working modal of a human organ that can be used by pharma companies for drug discovery models. Our moonshot is to be able to produce a transplantable human artificial organ that can one day put an end to mortality rate due to non-availability of transplantable human organs.

We are essentially a B2B business where doctors and hospitals, research institutes, pharma companies etc., are our clients, but we regularly get approached by a number of patients both from India and abroad who want our protocols for treatment. We do provide B2C services to such patients also.

We are currently operating out of our centralised lab in Noida, Delhi/NCR and are able to ship cells to various hospitals not just across India but also in various countries around the world.

Does India have well-defined stem cell treatment regulations?

Surprisingly very well. India has been always been a follower especially when it comes to medical research. There has hardly been any major medical innovation that has come out of India but things seem to be changing this time. It looks like there will be a good case study where India might just take the lead in stem cell technology and be a world leader in it. We have all the required resources and brainpower to make it happen, all we need is a supportive legislature, progressive regulators, understanding investors and gritty innovators and you will see things rolling.

The Government of India has started promoting Stem Cell Research with the help of its agencies. The focus is on identifying diseases and conditions that can be cured. Programmes to support embryonic and adult stem cell research are in place. Some of the developments include setting up human embryonic stem cell lines, using limbal stem cells to repair corneal surface disorder; classification of haematopoietic, mesenchymal and liver stem cells; as well as segregation of stem cells into neural, cardiac and cell lineages, etc.

For the rest of the world, there are many researchers who are creating pathbreaking records. Scientists from the University of California, for instance, have created an approach via stem cells to deal with cancerous tissue while anticipating some dangerous reactions of chemotherapy by treating the disease in a progressive manner.

So whats the scope for stem cell research/ therapy?

Stem cells present a unique opportunity to treat the disease that currently is termed as untreatable. They also help us in treating the diseases from the core and not just managing the symptoms. These properties give regenerative medicine a unique status.

You conduct 15-20 treatment in a month despite the unclear regulations in India? Do you see this as a challenge and deal with it?

We deal only with hospitals and doctors who have taken permission from the government and hence the reach is very low.

How do you differentiate your therapies from other existing players? What all guideline you follow and what is the success ratio?

There is no real credible competition for us. The big players in the market are primarily into cord blood banking and for the therapy is a side product on which they dont concentrate. There are few doctors who practice regenerative medicine on their own but could never match up with the product catalogue or research backing that we have.

There is an exhaustive consent form and clear inclusion and exclusion criterion and the patients are council-led at multiple points before the procedure.

Which are the therapeutic areas Advancells provides stem cell solutions and how safe are they? What is your future plan?

Advancells provide stem cell solutions for orthopaedics, neurology, diabetes etc. It is completely safe. We are targeting to venture into Cosmetics, Ophthalmology.

[emailprotected]

[emailprotected]

Originally posted here:
Lack of investment is the biggest challenge in stem cell research - Express Healthcare

Cardiac Stem Cells Comments Off on Lack of investment is the biggest challenge in stem cell research – Express Healthcare | April 30th, 2020