3 women blinded after receiving stem cell therapy for macular degeneration – ClickLancashire
By daniellenierenberg
The new report says the three women, in their 70s and 80s, paid $5,000 to be treated in 2015 for age-related macular degeneration. Participants can also report their concerns to the Office for Human Research Protections within the U.S. Department of Health and Human Services.
The "devastating outcomes" experienced by the women raise the "need for oversight of such clinics and for the education of patients by physicians and regulatory bodies", the paper said.
The women all suffered detached retinas, vision loss, and hemorrhages in their eyes.
"We don't mean to say all stem cell clinical studies are risky", coauthor Dr. Thomas Albini of the University of Miami told Reuters Health in a telephone interview.
Paul Knoepfler, a stem-cell scientist at the University of California at Davis who is a frequent critic of the clinics, said he didn't understand why the FDA and the NIH have not moved more aggressively to ensure patient safety. They sought treatment at a Florida clinic that had announced a study to treat the condition on clinicaltrials.gov, a federal database of research studies. Two out of the three patients found the trial through the website, which doesn't fully vet trials for scientific soundness. "Platelet count increased to 1.01m3 following the treatment and there were remarkable improvements in other symptoms", said Geeta Shroff, Stem Cell Specialist, Director, Nutech Mediworld. Stem cell clinics have cropped up all over the United States in recent years and are operating in a self-perceived regulatory loophole. Stem cells were then extracted from the fat and injected into their eyes. Albini says the complications could have come from injecting a contaminant into the eye, or from the fact that the stem cells may have turned into myofibroblasts after the injections, which are cells associated with scarring.
The Japanese case marks the first time anyone has given induced pluripotent stem (iPS) cells to a patient to treat any condition.
Legitimate medical research seldom requires patients to pay and, in the case of eye treatments, only one eye is treated at a time so doctors can gauge its effectiveness, the Kuriyan team said.
Although the women had moderate vision loss prior to the stem cell treatments, a year later their vision ranged from total blindness to 20/200, which is considered legally blind.
And even if the interventions were done well, they say, there is no evidence that they could have restored the patients' vision. They first cultivate stem cells to form the retinal pigmented epithelial cells that are needed to restore a damaged retina.
Shoddy stem cell preparation may have led to some of the complications, said the study authors.
The episode, described Wednesday in an article in the New England Journal of Medicine, represents one of the most egregious examples of patient injury involving a stem-cell clinic. The company also noted that it does not now treat eye patients.
The paper also mentions that the women believed that they were taking part in a clinical trial because they were aware of the clinic's work on the ClinicalTrials.gov website run by the U.S. National Library of Medicine. In other words, the company claims the study was stopped before patients were enrolled. In fact, doctors have done bone marrow transplant, a procedure where stem cell transplantation is performed.
"There's this perception that there are all these stem cell therapies out there that are close to clinical application that. are being held back by regulators and if they just step back, there would be all these treatments", he said. However, it can be hard for patients to distinguish between trials that are legitimate, and those that are not, the authors wrote.
"There's no excuse for not designing a trial properly and basing it on preclinical research", added study Jeffrey Goldberg, also a study author, of Stanford University's School of Medicine.
Researchers from the Luxembourg Centre for Systems Biomedicine (LCSB) of the University of Luxembourg and an global team have now identified an ingenious mechanism by which the body orchestrates the regeneration of red and white blood cells from progenitor cells.
See if a trial is affiliated with an academic medical center - that's a good sign it is legitimate, they say.
Read the original here:
3 women blinded after receiving stem cell therapy for macular degeneration - ClickLancashire
- Exclusive: Cell therapy startup Shinobi adds Borges as science chief, Katz as top medical officer - Endpoints News - December 18th, 2024
- Sumitomo Chemical and Sumitomo Pharma to Establish Regenerative Medicine and Cell Therapy Joint Venture - - December 18th, 2024
- Shinobi Strengthens Leadership to Propel Scalable Immune-Evasive Cell Therapies to the Clinic - The Eastern Progress Online - December 18th, 2024
- BrightPath Bio and Cellistic Announces Process Development and Manufacturing Collaboration for Phase 1 Clinical Trial of iPSC-derived BCMA CAR-iNKT... - December 18th, 2024
- Induced Pluripotent Stem Cells: Problems and Advantages when Applying ... - December 9th, 2024
- How Minaris is Tackling the Scalability Challenge in Cell and Gene Therapy: A Conversation with CEO, Dr. Hiroto Bando - geneonline - November 29th, 2024
- Toward Personalized Cell Therapies by Using Stem Cells 2013: BioMed Research International - Wiley Online Library - November 15th, 2024
- Cell therapy for heart disease and therapeutic cloning: will embryos re-enter the stem cell race? - Genethique - November 15th, 2024
- Cutting-edge stem cell therapy proves safe, but will it ever be ... - AAAS - November 6th, 2024
- Induced pluripotent stem cell - Wikipedia - October 21st, 2024
- What are iPS cells? | For the Public | CiRA | Center for iPS Cell ... - October 21st, 2024
- Nobel Winner Shinya Yamanaka: Cell Therapy Is Very Promising For Cancer, Parkinsons, More - Forbes - October 13th, 2024
- iPSCs Manufacturing for Cell-Based Therapies: A Market Analysis of Cell Types, Therapeutic Applications, Ma... - WhaTech - August 4th, 2024
- Abu Dhabi Stem Cells Center partners with Japan-based Kyoto University and Rege Nephro - ZAWYA - January 14th, 2024
- Eterna Therapeutics Enters Into Option and License Agreement with Lineage Cell Therapeutics to Develop Hypoimmune Pluripotent Cell Lines for Multiple... - March 1st, 2023
- What is an Intrusion Prevention System? Definition ... - Fortinet - January 27th, 2023
- What is an IPS Monitor? Monitor Panel Types Explained ... - January 27th, 2023
- IPS panel - Wikipedia - January 27th, 2023
- Cell and gene therapy products: what is an ATMP? - The Niche - January 3rd, 2023
- Cell Therapy - an overview | ScienceDirect Topics - November 22nd, 2022
- Ayala Pharmaceuticals Reports Third Quarter 2022 Financial Results and Provides Corporate Update - November 6th, 2022
- Aligos Therapeutics Presents Clinical Data for its Capsid Assembly Modulator, ALG-000184, at AASLD’s The Liver Meeting® 2022 - November 6th, 2022
- Correcting and Replacing: CinCor Reports Third Quarter Financial Results and Provides Corporate Update - November 6th, 2022
- NGM Bio Announces Poster Presentation Featuring Preclinical Characterization of NGM936 at Upcoming 2022 ASH Annual Meeting - November 6th, 2022
- Assembly Biosciences Presents New Data at AASLD The Liver Meeting® Highlighting Breadth of Virology Portfolio and Potential of Next-Generation Core... - November 6th, 2022
- CymaBay Therapeutics Presents Additional Analyses from Clinical Studies of Seladelpar for Patients with Primary Biliary Cholangitis at The Liver... - November 6th, 2022
- Immutep Announces Abstract Highlighting Eftilagimod Alpha Selected for SITC 2022 Annual Meeting Press Conference - November 6th, 2022
- Osteal Therapeutics, Inc. Completes Enrollment in APEX Phase 2 Clinical Trial of VT-X7 for Periprosthetic Joint Infection - November 6th, 2022
- PMV Pharmaceuticals Appoints Industry Veteran Dr. Carol Gallagher to Board of Directors - November 6th, 2022
- ORYZON to Give Updates on Corporate Progress in November - November 6th, 2022
- Terns Pharmaceuticals Highlights Results from Phase 1 Clinical Trial of TERN-501 at AASLD The Liver Meeting® 2022 - November 6th, 2022
- Aligos Therapeutics Presents Clinical Data for its NASH Program and Nonclinical Data for its Chronic Hepatitis B Portfolio at AASLD’s The Liver... - November 6th, 2022
- First U.S. patient receives autologous stem cell therapy to treat dry ... - October 29th, 2022
- BREAKTHROUGH TECHNOLOGY FOR IPS-DERIVED CELL THERAPIES TURNED INTO GMP PLATFORM BY TREEFROG THERAPEUTICS & INVETECH - Yahoo Finance - October 13th, 2022
- iPS-Cell Based Cell Therapies for Genetic Skin Disease - October 5th, 2022
- Jcr Pharmaceuticals Co., Ltd. and Sysmex Establish A Joint Venture in the Field of Regenerative Medicine and Cell Therapy - Marketscreener.com - October 5th, 2022
- MeiraGTx Announces the Upcoming Presentation of 15 Abstracts at the European Society of Gene and Cell Therapy (ESGCT) 2022 Annual Congress - Yahoo... - October 5th, 2022
- Stem Cells Market Size Expected to Reach USD 19.31 Billion by 2028: Increasing Number of Clinical Trials Across the Globe - Digital Journal - September 27th, 2022
- Implanting a Patient's Own Reprogrammed Stem Cells Shows Early Positive Results for Treating Dry AMD - Everyday Health - September 19th, 2022
- Current status of umbilical cord blood storage and provision to private biobanks by institutions handling childbirth in Japan - BMC Medical Ethics -... - September 19th, 2022
- Global Induced Pluripotent Stem Cells Market (2022 to 2027) - Growth, Trends, Covid-19 Impact and Forecasts - ResearchAndMarkets.com - Business Wire - September 11th, 2022
- Clinical translation of stem cell therapy for spinal cord injury still premature: results from a single-arm meta-analysis based on 62 clinical trials... - September 11th, 2022
- Improving the differentiation potential of pluripotent stem cells by optimizing culture conditions | Scientific Reports - Nature.com - August 26th, 2022
- New research digs into the genetic drivers of heart failure, with an eye to precision treatments - STAT - August 10th, 2022
- Creative Biolabs Leads the Forefront of iPSC Technology - Digital Journal - August 10th, 2022
- The zinc link: Unraveling the mechanism of methionine-mediated pluripotency regulation - EurekAlert - July 25th, 2022
- Live Cell Metabolic Analysis Paving the Way for Metabolic Research and Cell & Gene Therapy, Upcoming Webinar Hosted by Xtalks - Benzinga - July 16th, 2022
- PROMISING STEM CELL THERAPY IN THE MANAGEMENT OF HIV & AIDS | BTT - Dove Medical Press - July 8th, 2022
- Gene & Cell Therapy FAQs | ASGCT - American Society of Gene & Cell ... - June 30th, 2022
- The benefits and risks of stem cell technology - PMC - June 30th, 2022
- The Future of Parkinson Disease Therapies and the Challenges With Stem Cell Therapies - Neurology Live - June 20th, 2022
- Umoja Biopharma and TreeFrog Therapeutics Announce Collaboration to Address Current Challenges Facing Ex Vivo Allogeneic Therapies in Immuno-Oncology... - June 11th, 2022
- Newsletter April 2022 - Progress in Cline's cell lab and in the stem cell therapy field - Marketscreener.com - April 29th, 2022
- Healios K K : Joint Research with the Division of Regenerative Medicine, the Institute of Medical Science for Developing a Mass Production Method of... - April 3rd, 2022
- A combat with the YAP/TAZ-TEAD oncoproteins for cancer therapy - March 22nd, 2022
- The Pipeline for of iPSC-Derived Cell Therapeutics in 2022 ... - March 22nd, 2022
- Cell Therapy Processing Market CAGR of 27.80% Share, Scope, Stake, Trends, Industry Size, Sales & Revenue, Growth, Opportunities and Demand with... - January 3rd, 2022
- Stem cell therapy for diabetes - PubMed Central (PMC) - November 22nd, 2021
- Stem cells: Therapy, controversy, and research - October 5th, 2021
- How much does stem cell therapy cost in 2021? - The Niche - October 5th, 2021
- "Stem cell-based therapeutics poised to become mainstream option - BSA bureau - October 5th, 2021
- Exclusive Report on Stem Cell Therapy in Cancer Market | Analysis and Opportunity Assessment from 2021-2028 |Aelan Cell Technologies, Baylx, Benitec... - August 6th, 2021
- Asia-Pacific Cell Therapy Market 2021-2028 - Opportunities in the Approval of Kymriah and Yescarta - PRNewswire - August 6th, 2021
- Base Editing as Therapy for Common Inherited Lung and Liver Disease Shows Promise - Clinical OMICs News - July 22nd, 2021
- MoHAP, EHS reveal immunotherapy for cancer, viral infections at Arab Health 2021 - WAM EN - June 25th, 2021
- Kiromic Announces Expansion of In-House Cell therapy cGMP Manufacturing Facility and the Appointment of Industry Veteran Ignacio Nez as Chief... - June 8th, 2021
- Cryopreservation Media helps in Development of a Cell Therapy for Parkinson's Disease - Microbioz India - June 8th, 2021
- Accelerated Biosciences' Immune-Privileged Human Trophoblast Stem Cells (hTSCs) Offer Breakthrough Opportunities in Cancer-Targeting Therapeutics and... - May 15th, 2021
- Factor Bioscience to Deliver Six Digital Presentations at the American Society of Gene & Cell Therapy (ASGCT) 24th Annual Meeting - PRNewswire - May 15th, 2021
- St. Jude's $11.5B, six-year plan aims to improve global outcomes for children with cancer and catastrophic diseases - The Cancer Letter - May 15th, 2021
- Synthego Launches Eclipse Platform to Accelerate Research and Development of Next-generation Medicines - The Scientist - April 19th, 2021
- The Google Play video app will leave Roku, Vizio, LG and Samsung's TV platforms - Yahoo Canada Finance - April 19th, 2021
- New Controversy for Stem Cell Therapy That Repairs Spinal Cords - The Great Courses Daily News - March 8th, 2021
- Brentuximab Vedotin Plus Chemotherapy Works as a Primary Option for Hodgkin Lymphoma - Targeted Oncology - March 8th, 2021
- Induction of muscle-regenerative multipotent stem cells from human adipocytes by PDGF-AB and 5-azacytidine - Science Advances - January 14th, 2021
- A Potential Therapy for One of the Leading Causes of Heart Disease - PRNewswire - December 10th, 2020
- Evotec and Sartorius Partner with Start-Up Curexsys on IPSC-Based Therapeutic Exosome Approach - BioSpace - December 9th, 2020
- Induced Pluripotent Stem Cell (iPS Cell) Applications in 2020 - November 28th, 2020
- Induced Pluripotent Stem Cell - an overview ... - November 28th, 2020
- The Stem Cell-Derived Cells market to Scale new heights in the next decade - Khabar South Asia - November 28th, 2020