– Similar clinical remission rates observed in patients receiving AMT-101 monotherapy compared to placebo at week 12

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Applied Molecular Transport Announces Top-line Phase 2 Results from LOMBARD Monotherapy Trial of Oral AMT-101 in Patients with Moderate-to-Severe...

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NEW YORK, Dec. 22, 2022 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that funds managed by Oaktree Capital Management, L.P. (“Oaktree”) have extended to Mesoblast the availability of up to an additional US$30.0 million of its US$90 million five year facility subject to achieving certain milestones on or before September 30, 2023.

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Mesoblast and Oaktree Extend Availability Period of Undrawn Tranches of Financing Facility

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Saint-Herblain (France), December 23, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that it has completed rolling submission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its single-shot chikungunya vaccine candidate, VLA1553. Valneva is seeking approval of its investigational chikungunya vaccine in persons aged 18 years and above.

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Valneva Completes BLA Submission to U.S. FDA for its Single-Shot Chikungunya Vaccine Candidate

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Basel/Allschwil, Switzerland, December 23, 2022

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Basilea announces regulatory approval of antifungal Cresemba® (isavuconazole) in Japan

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Montrouge, France, December 23, 2022

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DBV Technologies Announces FDA Has Lifted Partial Clinical Hold on VITESSE Phase 3 Pivotal Trial  

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COPENHAGEN, Denmark, December 23, 2022 – Bavarian Nordic A/S (OMX: BAVA) announced today a new agreement with the U.S. Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), for the advanced development of MVA-BN® WEV, a prophylactic vaccine candidate against Western, Eastern and Venezuelan equine encephalitis virus, which can cause a rare, but potentially deadly mosquito-borne illness in humans1. Currently, no approved vaccines for human use are available.

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Bavarian Nordic Enters Agreement Valued up to USD 83 Million with the U.S. Department of Defense to Further Advance the Development of Equine...

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MAINZ, Germany, December 23, 2022 – BioNTech SE (Nasdaq: BNTX, “BioNTech”, "the Company") today announced the initiation of a first-in-human Phase 1 study with BNT165b1, the first candidate from the Company’s BNT165 program, to develop a multi-antigen malaria vaccine candidate. BioNTech will initially evaluate a set of mRNA-encoded antigens of the malaria-causing parasite Plasmodium falciparum (P. falciparum) to help select the multi-antigen vaccine candidate to proceed to planned later-stage trials. This first clinical trial (NCT05581641) will evaluate the safety, tolerability and exploratory immunogenicity of the vaccine candidate BNT165b1. BNT165b1 expresses certain parts of the circumsporozoite protein (CSP).

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BioNTech Initiates Phase 1 Clinical Trial for Malaria Vaccine Program BNT165

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OSLO, Norway, Dec. 23, 2022 (GLOBE NEWSWIRE) -- Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, today announced that its Chief Executive Officer Michael Engsig will present at the 41st Annual J.P. Morgan Healthcare Conference on Monday, January 9, 2023 at 1:30 p.m. PT / 10:30 p.m. CET.

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Nykode Therapeutics to Present at the 41st Annual J.P. Morgan Healthcare Conference

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-   This two-part phase 1 trial in healthy volunteers was designed to assess the safety, pharmacokinetics, and analgesic activity of KUR-101

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atai Life Sciences Announces Results from the Kures Therapeutics Phase 1 Trial of KUR-101

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NDA supported by robust NASH clinical development program, including two positive interim analyses from the Phase 3 REGENERATE study

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Intercept Resubmits New Drug Application to U.S. FDA for Obeticholic Acid in Patients with Liver Fibrosis due to NASH

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SYDNEY, AUSTRALIA, Dec. 23, 2022 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces the results of a positive follow-up Type C meeting with the US Food and Drug Administration (FDA) regarding late-stage clinical development plans for its first-in-class soluble LAG-3 protein, eftilagimod alpha (“efti”), in conjunction with standard-of-care chemotherapy for the treatment of metastatic breast cancer (MBC). The Company and the FDA have agreed to an integrated Phase II/III trial design that will help inform a Biologics License Application (BLA).

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Immutep Announces Successful Meeting with the FDA on Eftilagimod Alpha plus Chemotherapy for the Treatment of Metastatic Breast Cancer

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VANCOUVER, Washington, Dec. 23, 2022 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, will hold a webcast on December 29, 2022 at 8:00 a.m. Pacific Time (11:00 a.m. Eastern Time) to discuss the performance of leronlimab in its clinical trials and the recent charges against its former CEO Nader Pourhassan, who was previously terminated on January 24, 2022, and has had no affiliation with the Company since that time.

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CytoDyn to Hold Webcast to Discuss the Performance of Leronlimab in Clinical Trials and Recent Charges Against Former CEO

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Japan is the first country in the world to approve NexoBrid for people of all ages; pediatric and adult populations

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MediWound Expands NexoBrid’s Global Presence with Marketing Approval in Japan

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Basel, 23 December 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved Lunsumio® (mosunetuzumab-axgb) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Lunsumio, a CD20xCD3 T-cell engaging bispecific antibody, represents a new class of fixed-duration cancer immunotherapy, which is off-the-shelf and readily available, so that patients do not have to wait to start treatment. Lunsumio will be available in the United States in the coming weeks. “This approval is a significant milestone for people with relapsed or refractory follicular lymphoma, who have had limited treatment options until now,” said Elizabeth Budde, M.D., Ph.D., Haematologic Oncologist and Associate Professor, City of Hope Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation, and Lunsumio clinical trial investigator. “As a first-in-class T-cell engaging bispecific antibody that can be initiated in an outpatient setting, Lunsumio’s high response rates and fixed-duration could change the way advanced follicular lymphoma is treated.”“Despite treatment advances, follicular lymphoma remains incurable and relapse is common, with outcomes worsening following each consecutive treatment,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Lunsumio represents our first approved T-cell engaging bispecific antibody and builds on our legacy of more than 20 years of innovation in blood cancer.”The FDA approval is based on positive results from the phase II GO29781 study of Lunsumio in people with heavily pre-treated FL, including those who were at high risk of disease progression or whose disease was refractory to prior therapies. Results from the study showed high and durable response rates. An objective response was seen in 80% (72/90 [95% confidence interval (CI): 70-88]) of patients treated with Lunsumio, with a majority maintaining responses for at least 18 months (57% [95% CI: 44-70]). The objective response rate is the combination of complete response (CR) rate (a disappearance of all signs and symptoms of cancer) and partial response rate (a decrease in the amount of cancer in the body). The median duration of response among those who responded was almost two years (22.8 months [95% CI: 10-not reached]). A CR was achieved in 60% of patients (54/90 [95% CI: 49-70]). Among 218 patients with haematologic malignancies who received Lunsumio at the recommended dose, the most common adverse event (AE) was cytokine release syndrome (CRS; 39%), which can be severe and life-threatening. The median duration of CRS events was three days (range: 1-29). Other common AEs (?20%) included fatigue, rash, pyrexia and headache.Lunsumio is administered as an intravenous infusion for a fixed-duration, which allows for time off therapy, and can be infused in an outpatient setting. Hospitalisation may be needed to manage select AEs, should be considered for subsequent infusions following a Grade 2 CRS event, and is recommended for subsequent infusions following a Grade 3 CRS event.Lunsumio was developed based on the Roche Group's broad expertise in creating bispecific antibodies. Lunsumio is designed to address the diverse needs of people with blood cancer, physicians, and practice settings, and is part of the company’s robust bispecific antibody clinical programme in lymphoma. Lunsumio is being further investigated as a subcutaneous formulation (i.e., administered under the skin) and in phase III studies that will expand the understanding of its impact in earlier lines of treatment in people with non-Hodgkin lymphoma.About the GO29781 studyThe GO29781 study [NCT02500407] is a phase II, multicentre, open-label, dose-escalation and expansion study evaluating the safety, efficacy and pharmacokinetics of Lunsumio® (mosunetuzumab-axgb) in people with relapsed or refractory B-cell non-Hodgkin lymphoma. Outcome measures include complete response rate (best response) by independent review facility (primary endpoint), objective response rate, duration of response, progression-free survival, safety, and tolerability (secondary endpoints).About follicular lymphomaFollicular lymphoma (FL) is the most common slow-growing (indolent) form of non-Hodgkin lymphoma, accounting for about one in five cases.1 It typically responds well to treatment but is often characterised by periods of remission and relapse. The disease typically becomes harder to treat each time a patient relapses, and early progression can be associated with poor long-term prognosis. It is estimated that, in the United States, approximately 13,000 new cases of FL will be diagnosed in 2022 and more than 100,000 people are diagnosed with FL each year worldwide.1,2About Lunsumio® (mosunetuzumab-axgb)Lunsumio is a first-in-class CD20xCD3 T-cell engaging bispecific antibody designed to target CD20 on the surface of B-cells and CD3 on the surface of T-cells. This dual targeting activates and redirects a patient’s existing T-cells to engage and eliminate target B-cells by releasing cytotoxic proteins into the B-cells. A robust clinical development programme for Lunsumio is ongoing, investigating the molecule as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin lymphomas, including follicular lymphoma and diffuse large B-cell lymphoma, and other blood cancers.About Roche in haematologyRoche has been developing medicines for people with malignant and non-malignant blood diseases for more than 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab) and Lunsumio® (mosunetuzumab-axgb). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibodies, glofitamab, targeting both CD20 and CD3, and cevostamab, targeting both FcRH5 and CD3; Tecentriq® (atezolizumab), a monoclonal antibody designed to bind with PD-L1 and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

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FDA approves Roche’s Lunsumio, a first-in-class bispecific antibody, to treat people with relapsed or refractory follicular lymphoma

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Mechelen, Belgium; 23 December 2022, 22.01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) received a transparency notification from FMR LLC.

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Galapagos receives transparency notification from FMR LLC

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- FDA has been unable to travel to China to conduct the required site inspection resulting in delayed action on the BLA -

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Coherus and Junshi Biosciences Share Update on the FDA Review of the Biologics License Application (BLA) for Toripalimab as Treatment for Recurrent or...

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A bone marrow transplant is a medical treatment that replaces your bone marrow with healthy bone marrow stem cells. It is also called a stem cell transplant or, more specifically, a hematopoietic stem cell transplant. This type of transplantation can treat certain types of cancer and other diseases that affect the bone marrow. Like any cancer treatment, it can cause side effects. These side effects can be different for everyone and depend on the type of transplant you receive, your general health, and other factors.

It is a good idea to talk with your health care team about the possible side effects before starting your transplant process. This includes short-term side effects that are expected to go away over time, as well as side effects that may occur later, last longer, or be permanent. This will help you feel more prepared and supported if a side effect does occur.

And, talk with your health care team regularly about any symptoms or side effects you experience throughout your transplantation process and recovery. This includes when a side effect worsens or a new problem appears. Managing side effects is an important part of cancer care and treatment and it is especially important during transplantation. This type of care is called palliative or supportive care. It can help people with any stage of cancer feel better.

There are different kinds of bone marrow transplants and the side effects can be different. The side effects for an autologous transplant and an allogenic transplant are detailed below.

An autologous bone marrow transplant is also called an AUTO transplant or stem cell rescue. During an AUTO transplant, your own stem cells are removed from your body before an intensive chemotherapy treatment. This intensive treatment, which can also include radiation therapy, damages your stem cells. The healthy stem cells are then put back in your body to "replace" the ones damaged by the treatment.

Many side effects of an AUTO transplant are similar to common side effects of chemotherapy and radiation therapy. The most serious side effect is a higher risk of infection from your body's low levels of white blood cells.

Infection. Chemotherapy and some other treatments weaken your body's infection-fighting system, called the immune system. This is especially true of treatment given for a bone marrow/stem cell transplant, because the bone marrow is part of the immune system. When your immune system is weakened, your body cannot protect itself as well against germs. Most of these germs already live in your body. When your immune system is strong, these germs do not make you sick. But after a transplant, they can cause an infection. Fortunately, most of these infections can be easily treated with antibiotics.

About 2 weeks after your transplant day, your immune system will begin to recover. You have the highest risk of infections in the first few weeks after transplant, but you will still be at a higher risk of infections for a year or more after. Your health care team will talk to you about ways to reduce your risk of infections during your recovery. Learn more about infections as a side effect of cancer treatment.

Other immediate side effects of AUTO transplants. The following side effects can develop right after the high doses of chemotherapy used for AUTO transplants:

Long-term side effects of AUTO transplants. Some transplant side effects happen months or years later. These can include:

An allogenic transplant is also called an ALLO transplant. In an ALLO transplant, the replacement cells come from another person, called a donor. After a round of chemotherapy and sometimes radiation therapy, you will receive the donor's healthy cells.

The side effects of an ALLO transplant are similar to common side effects of chemotherapy and radiation therapy. This includes a high risk for infections. You are also at risk of side effects caused by having another person's stem cells, including a risk of graft-versus-host disease (GVHD; see below). Many people also have a "graft-versus-cancer-cell effect" along with GVHD. This is because the new stem cells recognize and destroy cancer cells that are still in the body. It is the main way ALLO transplants work to cure cancers like leukemia.

Infection. After an ALLO transplant, your doctor will give you chemotherapy, with or without radiation therapy or other drugs, to keep your body's immune system from destroying the new donated cells. These treatments affect your immune system and make infection risk higher. A weak immune system makes you more likely to get infections.

You are at the highest risk of infection in the first few weeks after receiving the donor's cells. The risks lessen over time, but infection risk reduction is an important part of your long-term recovery.

Graft-versus-host disease (GVHD). Sometimes donor cells can attack your body, causing inflammation. This is a specific side effect of ALLO transplantation called GVHD. Even if your donor was a 100% match, you can still get GVHD. Your health care team can give you medication to prevent GVHD. If you still experience GVHD, your doctor will give you more medications to manage the condition. GVHD can be life-threatening in some cases.

There are 2 types of GVHD: acute and chronic. Both can range from mild to severe.

This form of GVHD happens in the first 3 months after an ALLO transplant. It often affects the skin, intestines, and liver. It can cause rashes, diarrhea, and jaundice. Jaundice is a liver problem that makes skin and the whites of the eyes look yellow.

The treatment for acute GVHD is to block T cells. T cells are white blood cells that help the immune system fight infections. Blocking them keeps your transplanted immune system from attacking your body's own cells.

Chronic GVHD usually develops more than 3 months after an ALLO transplant. It can last a few months or the rest of your life.

Chronic GVHD may or may not cause symptoms or need treatment. You may need treatment for specific problems. Some common problems of chronic GVHD include:

There are 2 medications approved by the U.S. Food and Drug Administration (FDA) to treat chronic graft-versus-host disease.

Ruxolitinib (Jakafi) in adults and children 12 years and older after 1 or more treatments with systemic therapy

Ibrutinib (Imbruvica) in children 1 year and older after 1 or more treatments with systemic therapy

Chronic GVHD can be treated with medications called corticosteroids. If this does not work well, you might take other medications to make your immune system less active.

Other immediate side effects. Side effects that can develop right after the high doses of chemotherapy used for ALLO transplantation include the following.

Late or long-term side effects. Some transplantation side effects can happen months or years later. These can include:

People who have less powerful chemotherapy treatments before their transplant tend to have fewer long-term physical effects.

Talk with your health care team about possible physical side effects of your bone marrow transplant, as well as what signs to watch for. They can help answer your questions and make a plan to manage short-term and long-term side effects.

Bone marrow transplantation is an extended medical process, and many people experience a variety of emotional and social challenges during this treatment and recovery. This can include anxiety and depression. It can also include the uncertainty and stress that cancer brings, self-image changes, changes in relationships with loved ones, feelings of isolation, and grieving losses from cancer and its treatment.

Be sure to share your feelings, including with your health care team. They want to know how you are feeling during and after transplantation. There are many ways to help support your mental health during this stressful time, including counseling, joining a support group, journaling, art therapy, mindfulness, and meditation.

It is important to talk often with your health care team about different types of side effects, before, during, and after your transplant. This helps you gather information and make decisions on treatment and care. Here are some possible questions to ask.

What tests will be done before the transplant process starts to check my general health?

When could I start to experience side effects during this process?

What specific side effects are common with this type of transplant? How can each one be managed or relieved?

Who should I call if I experience any side effects from my transplant?

What signs of an infection should I look out for?

What precautions to prevent infection should I follow? For how long?

What side effects should I tell my health care team right away?

If I will have an ALLO transplant, will I take any medications to prevent GVHD?

If I will have an ALLO transplant, what are the signs of GVHD that I should watch for?

What tests will I need later? How often?

What are the possible late effects of a transplant? How can they be managed or relieved?

How will having a transplant affect my daily life? Can I work? Can I exercise and do regular activities? Or, when can I restart these activities during my recovery?

Will having a transplant affect my sex life? If so, how and for how long?

Will having this transplant affect my ability to have a child in the future? If so, can you refer me to a fertility specialist before treatment begins?

Why is good nutrition important during and after a transplant? Should I meet with an oncology registered dietitian?

Who can I talk with about the emotional effects of cancer and this treatment?

What can I do at home to keep myself as healthy as possible?

What is a Bone Marrow Transplant (Stem Cell Transplant)?

Resources on Bone Marrow/Stem Cell Transplant

Coping With the Fear of Treatment-Related Side Effects

Survivorship

Bone Marrow Transplant and Older Adults

Be the Match: Life After Transplant

Be the Match: GVHD Signs and Symptoms

BMT InfoNet: Transplant Basics

National Bone Marrow Transplant Link: Publications on Side Effects and Survivorship

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Side Effects of a Bone Marrow Transplant (Stem Cell Transplant)

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RUDN Physician And Russian Scientists Investigate Long-term Effects Of Treating Diabetic Ulcers With Stem Cells  India Education Diary

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RUDN Physician And Russian Scientists Investigate Long-term Effects Of Treating Diabetic Ulcers With Stem Cells - India Education Diary

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An organoid model of colorectal circulating tumor cells with stem cell ...

Cardiac Stem Cells Comments Off on An organoid model of colorectal circulating tumor cells with stem cell … | December 25th, 2022

A heart surgeon, Professor Massimo Caputo from the Bristol Heart Institute has stated he "saved the life" of a baby by carrying out a "world-first" operation using stem cells from placentas.

Professor Massimo Caputo used pioneering stem cell injections to correct baby Finley's heart defect and says he now hopes to develop the technology so children born with congenital cardiac disease won't need much surgical operations.

Finley was born with the main arteries in his heart positioned the wrong way round and at just four days old had his first open-heart surgery at Bristol Royal Hospital for Children

Unfortunately the surgery did not solve the issue and his heart function deteriorated significantly, with the left side of the heart suffering from a severe lack of blood flow.

His mother, Melissa, from Corsham, in Wiltshire, said: "We were prepared from the start that the odds of him surviving were not good.

"After 12 hours, Finley finally came out of surgery but he needed a heart and lung bypass machine to keep alive, and his heart function had deteriorated significantly."

After weeks in intensive care it looked like there was no way to treat Finley's condition and he was reliant on drugs to keep his heart going.

But a new procedure was tried, involving stem cells from a placenta bank.

Prof Caputo injected the cells directly into Finley's heart in the hope they would help damaged blood vessels grow.

The so-called "allogeneic" cells were grown by scientists at the Royal Free Hospital in London, and millions of them were injected into Finley's heart muscle.

Allogeneic cells have the ability to grow into tissue that is not rejected and in Finley's case, have regenerated damaged heart muscle.

"We weaned him from all the drugs he was on, we weaned him from ventilation," said Prof Caputo.

"He was discharged from ITU and is now a happy growing little boy."

Finley is now aged two years.

Using a bio-printer, a stem cell scaffold is made to repair abnormalities to valves in blood vessels, and to mend holes between the two main pumping chambers of the heart.

In cardiac surgery, artificial tissue is normally used on babies for cardiac repairs, but it can fail and it does not grow with the heart, so as the children grow, they require more operations.

A child might therefore have to go through the same heart operation multiple times throughout its childhood but Prof Caputo and his team say the stem cell technology could save the UK government an estimated 30,000 for every operation no longer needed.

Dr Stephen Minger, an expert in stem cell biology and director of SLM Blue Skies Innovations Ltd said;

"Most studies that I am aware of in adults with heart dysfunction or failure show only minimal therapeutic benefit with stem cell infusion.

"I'm happy that the clinical team will go on to do a standard clinical trial which should tell us if this was a 'one-off' success and also give us some better understanding of mechanisms behind this."

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Baby's life saved by surgeon who carried out world's first surgery ...

Cardiac Stem Cells Comments Off on Baby’s life saved by surgeon who carried out world’s first surgery … | December 25th, 2022