Medical Dialogues
  • Dermatology
Login Register
This site is intended for healthcare professionals only
Login Register
  • Medical Jobs
  • Medical Matrimony
  • MD Brand Connect
  • MDTV
    • Breaking News
    • Medical News Today
    • Health News Today
    • Latest
    • Journal Club
    • Medico Legal Update
    • Latest Webinars
    • MD Shorts
    • Health Dialogues
Medical Dialogues
  • Medical News & Guidelines
      • Anesthesiology
      • Cardiology and CTVS
      • Critical Care
      • Dentistry
      • Dermatology
      • Diabetes and Endocrinology
      • ENT
      • Gastroenterology
      • Medicine
      • Nephrology
      • Neurology
      • Obstretics-Gynaecology
      • Oncology
      • Ophthalmology
      • Orthopaedics
      • Pediatrics-Neonatology
      • Psychiatry
      • Pulmonology
      • Radiology
      • Surgery
      • Urology
      • Laboratory Medicine
      • Diet
      • Nursing
      • Paramedical
      • Physiotherapy
  • Health news
      • Doctor News
      • Government Policies
      • Hospital & Diagnostics
      • International Health News
      • MCI News
      • Medical Organization News
      • Medico Legal News
      • NBE News
      • NMC News
  • AYUSH
    • Ayurveda
    • Homeopathy
    • Siddha
    • Unani
    • Yoga
  • State News
      • Andaman and Nicobar Islands
      • Andhra Pradesh
      • Arunachal Pradesh
      • Assam
      • Bihar
      • Chandigarh
      • Chattisgarh
      • Dadra and Nagar Haveli
      • Daman and Diu
      • Delhi
      • Goa
      • Gujarat
      • Haryana
      • Himachal Pradesh
      • Jammu & Kashmir
      • Jharkhand
      • Karnataka
      • Kerala
      • Ladakh
      • Lakshadweep
      • Madhya Pradesh
      • Maharashtra
      • Manipur
      • Meghalaya
      • Mizoram
      • Nagaland
      • Odisha
      • Puducherry
      • Punjab
      • Rajasthan
      • Sikkim
      • Tamil Nadu
      • Telangana
      • Tripura
      • Uttar Pradesh
      • Uttrakhand
      • West Bengal
  • Medical Education
      • Ayush Education News
      • Dentistry Education News
      • Medical Admission News
      • Medical Colleges News
      • Medical Courses News
      • Medical Universities News
      • Nursing education News
      • Paramedical Education News
      • Study Aborad
  • Industry
      • Health Investment News
      • Health Startup News
      • Medical Devices News
      • Pharma News
      • Pharmacy Education News
      • Industry Perspective
  • MDTV
      • Health Dialogues MDTV
      • Health News today MDTV
      • Latest Videos MDTV
      • Latest Webinars MDTV
      • MD shorts MDTV
      • Medical News Today MDTV
      • Medico Legal Update MDTV
      • Top Videos MDTV
      • Health Perspectives MDTV
      • Journal Club MDTV
This site is intended for healthcare professionals only
LoginRegister
Medical Dialogues
LoginRegister
  • Home
  • Medical news & Guidelines
    • Anesthesiology
    • Cardiology and CTVS
    • Critical Care
    • Dentistry
    • Dermatology
    • Diabetes and Endocrinology
    • ENT
    • Gastroenterology
    • Medicine
    • Nephrology
    • Neurology
    • Obstretics-Gynaecology
    • Oncology
    • Ophthalmology
    • Orthopaedics
    • Pediatrics-Neonatology
    • Psychiatry
    • Pulmonology
    • Radiology
    • Surgery
    • Urology
    • Laboratory Medicine
    • Diet
    • Nursing
    • Paramedical
    • Physiotherapy
  • Health news
    • Doctor News
    • Government Policies
    • Hospital & Diagnostics
    • International Health News
    • MCI News
    • Medical Organization News
    • Medico Legal News
    • NBE News
    • NMC News
  • AYUSH
    • Ayurveda
      • Ayurveda Giuidelines
      • Ayurveda News
    • Homeopathy
      • Homeopathy Guidelines
      • Homeopathy News
    • Siddha
      • Siddha Guidelines
      • Siddha News
    • Unani
      • Unani Guidelines
      • Unani News
    • Yoga
      • Yoga Guidelines
      • Yoga News
  • State News
    • Andaman and Nicobar Islands
    • Andhra Pradesh
    • Arunachal Pradesh
    • Assam
    • Bihar
    • Chandigarh
    • Chattisgarh
    • Dadra and Nagar Haveli
    • Daman and Diu
    • Delhi
    • Goa
    • Gujarat
    • Haryana
    • Himachal Pradesh
    • Jammu & Kashmir
    • Jharkhand
    • Karnataka
    • Kerala
    • Ladakh
    • Lakshadweep
    • Madhya Pradesh
    • Maharashtra
    • Manipur
    • Meghalaya
    • Mizoram
    • Nagaland
    • Odisha
    • Puducherry
    • Punjab
    • Rajasthan
    • Sikkim
    • Tamil Nadu
    • Telangana
    • Tripura
    • Uttar Pradesh
    • Uttrakhand
    • West Bengal
  • Medical Education
    • Ayush Education News
    • Dentistry Education News
    • Medical Admission News
    • Medical Colleges News
    • Medical Courses News
    • Medical Universities News
    • Nursing education News
    • Paramedical Education News
    • Study Aborad
  • Industry
    • Health Investment News
    • Health Startup News
    • Medical Devices News
    • Pharma News
      • CDSCO (Central Drugs Standard Control Organisation) News
    • Pharmacy Education News
    • Industry Perspective
  • Home
  • Diabetes and Endocrinology
  • Diabetes and Endocrinology News
  • FDA panel agrees on...

FDA panel agrees on islet cell transplant therapy for type 1 diabetes

Medha BaranwalWritten by Medha Baranwal Published On 2021-04-17T11:46:19+05:30  |  Updated On 2021-04-17T14:21:11+05:30
FDA panel agrees on islet cell transplant therapy for type 1 diabetes

USA: A US Food and Drug Administration (FDA) advisory committee has endorsed cadaveric allogeneic pancreatic islet cells (donislecel) for the treatment of people with type 1 diabetes that can't be managed with current therapies. On April 15, the members of the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee voted 12 to 4 in favor of donislecel (Lantidra) approval. According...

USA: A US Food and Drug Administration (FDA) advisory committee has endorsed cadaveric allogeneic pancreatic islet cells (donislecel) for the treatment of people with type 1 diabetes that can't be managed with current therapies. 

On April 15, the members of the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee voted 12 to 4 in favor of donislecel (Lantidra) approval. According to the committee, this procedure will likely benefit only a select few patients, the benefits of possible insulin independence for them outweigh the risks that come with long-term immunosuppressive treatment.

The product consists of purified allogeneic pancreatic islets of Langerhans derived from cadaveric donors and is infused into the portal vein of the liver.

The therapy's sponsor, CellTrans, explained that existing options are limited for the some 80,000 American adults estimated to have "brittle" type 1 diabetes -- a subset of type 1 characterized by a particularly refractory form of complete insulin deficiency where patients often have vast swings in blood glucose levels.

Those existing therapies include whole-pancreas transplantation (with or without concurrent kidney transplant) or tried-and-true insulin therapy, which can come in the form of multiple daily injections or a closed-loop insulin pump and continuous glucose monitoring system. 

Key findings of the trial include:

· Five patients (16.7%) in the phase III trial never became insulin dependent at any time during the average 6.5-year follow-up, one of whom received two transplants.

· In total, there were 1,319 adverse events reported during the first year after transplantation, eight of which were life-threatening and 75 severe.

· One patient in the phase III trial died due to multiorgan failure from an infection 592 days after initial transplant, which the sponsor deemed "probably related to immunosuppression/study drug."

· Life-threatening," adverse events included reports of neutropenia, anemia, breast cancer, hyperlipidemia, pancytopenia, papillary thyroid cancer, post-transplant lymphoproliferative disease, and urosepsis.

"There are two very small sub-populations that it would provide the only viable therapy," said Christopher Breuer, MD, of Nationwide Children's Hospital in Columbus, Ohio, on why he voted in favor. "Those would be the ones who are eligible for transplantation but couldn't tolerate a big operation... and those that were on the best standard-of-care -- the feedback responsive pumps -- but were not tolerating those."

Also voting "yes," Randy Hawkins, MD, of a private practice in Inglewood, California, said: "I do have concerns about the adverse effects of immunosuppressants. I think we should keep this in a toolbox, but I believe the patients need to be given strict informed consent about the risks."

Speaking as one of the four opposing voices, David Harlan, MD, of the University of Massachusetts Medical School in Worcester, said there may be some patients that could benefit from this option, but there are very few out there.

"There's only a hundred pancreas transplants done in this country every year and that's very effective," he said, adding "so were talking about patients who are not candidates for pancreas transplants that might get this."

"I voted no because I too take care of patients with diabetes and I have transplanted islets before -- I've done both and I've seen them both pre- and post-transplant. And I've seen the awful things that can happen in post-transplant recipients. It's really hard to get that informed consent from someone when you're asking them to consider a future that they don't know."

While islet cell transplantation is less invasive than a whole pancreas transplant, procedure risks include possible damage to the liver, gall bladder, and intra-abdominal blood vessels. Paired with those risks, the required immunosuppressive regimen can increase their risk for a slew of adverse events -- besides infection, these include cancers, neurological disorders, anemia, gastrointestinal events, and more.

"I look forward to further developments in immunosuppression that would mitigate the current toxicity that we're facing," Sandy Feng, MD, PhD, of the University of California San Francisco, said after casting her vote in favor of the therapy. "There are definitely additional therapies that are being developed that might mitigate those toxicities that would be beneficial to this population."

"I have taken care of patients -- I do pancreas transplants -- and I can tell you that there is nothing that a person likes more than their pancreas transplant and their freedom from dealing with the entire insulin issue," she added. "I think that this can help some people and I think that it would be incredibly meaningful to those people."

Although the FDA is not required to follow its advisory committees' recommendations, it typically does.

type 1 diabetes FDA donislecel 
Source : US FDA
Medha Baranwal
Medha Baranwal

    MSc. Biotechnology

    Medha Baranwal joined Medical Dialogues as an Editor in 2018 for Speciality Medical Dialogues. She covers several medical specialties including Cardiac Sciences, Dentistry, Diabetes and Endo, Diagnostics, ENT, Gastroenterology, Neurosciences, and Radiology. She has completed her Bachelors in Biomedical Sciences from DU and then pursued Masters in Biotechnology from Amity University. She has a working experience of 5 years in the field of medical research writing, scientific writing, content writing, and content management. She can be contacted at  editorial@medicaldialogues.in. Contact no. 011-43720751

    Show Full Article
    Next Story
    Similar Posts
    NO DATA FOUND

    Editorial

    Journal Club Today

    Health News Today

    © 2022 All Rights Reserved.
    Powered By: Hocalwire
    X
    X
    We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok