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ClinicalTrials.gov Identifier: NCT03791567
Expanded Access Status : Approved for marketing
First Posted : January 2, 2019
Last Update Posted : August 29, 2023
Sponsor:
Information provided by (Responsible Party):
Jose Oberholzer, University of Illinois at Chicago
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Brief Summary:
A Phase 3 clinical trial has been completed and demonstrated the safety and efficacy of allogeneic islet transplantation in improving glycemic control in Type 1 diabetic patients using the UIC protocol.The objective in offering expanded access to donislecel (allogeneic islets of Langerhans for transplant; IND BB-11807) for the treatment of brittle T1D is to bridge the gap between completed clinical trials and marketing (i.e. approval by the FDA of a biological license application). Expanded access will allow clinical trial subjects, as well as patients outside a clinical trial, to receive treatment. New patients participating in the expanded access protocol are required to meet exclusion and inclusion criteria.
Type 1 Diabetes Mellitus
Biological: Donislecel (allogeneic islets of Langerhans for transplant)
Detailed Description:
Expanded access to donislecel (allogeneic islets of Langerhans for transplant; IND BB-11807) is for the treatment of brittle T1D. Brittle T1D is a distinct subset of T1D, representing the most severe and difficult to manage manifestation of the disease. Standard therapies (i.e. exogenous insulin injections and insulin pumps) are not sufficient to regulate blood glucose levels for this subset of patients. Thus, the severity of disease and the lack of metabolic control that occur despite intensive insulin therapy in brittle T1D patients defines a patient population whose risk-benefit profile makes them suitable for islet transplantation. Eligible patients may receive one or several allogeneic pancreatic islet transplants. An independent Data Monitoring Committee (DMC), composed of 3 members who have training in medicine and/or organ transplantation, will review eligibility and safety data within 2 weeks after each islet transplantation and every two months thereafter. An independent monitor, who is knowledgeable about Good Clinical Practice (GCP) guidelines and regulations, monitors the study for compliance with 21 CFR and according to ICH GCP Guidelines. The UIC Institutional Review Board (IRB) reviews safety data annually and on occurrence of serious adverse events. The principal investigator also reports serious adverse events to the US Food and Drug Administration (FDA). Success, partial success, and failure criteria will be the same as indicated in the Phase III clinical trial. Patients will be closely monitored post-transplant by the UIC clinical team and/or their primary care physician for safety and efficacy.
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Study Type :
Expanded Access
Expanded Access Type :
Treatment IND/Protocol
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See clinical trials of the intervention/treatment in this expanded access record.
Official Title:
Expanded Access to Donislecel for Treatment Use
Resource links provided by the National Library of Medicine
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Intervention Details:
Biological: Donislecel (allogeneic islets of Langerhans for transplant)
Intervention Description: The drug product consists of allogeneic human islets of Langerhans (islets) in serum-free transplant medium (indicator-free CMRL 1066 medium with HEPES, without sodium bicarbonate and supplemented with human albumin).
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Information from the National Library of Medicine
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Ages Eligible for Study: Â
18 Years to 75 Years  (Adult, Older Adult)
Sexes Eligible for Study: Â
All
Inclusion Criteria:
Eligible subjects must have Type 1 diabetes mellitus for more than 5 years, complicated by the following situations that persist despite intensive insulin management efforts:
At least one episode of severe hypoglycemia in the past 3 years defined as an event with symptoms compatible with hypoglycemia in which the subject required the assistance of another person, and which was associated with either a blood glucose level < 50 mg/dL (2.8 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration
Reduced awareness of hypoglycemia, as defined by the absence of adequate autonomic symptoms at capillary glucose levels of < 54 mg/dL (3 mmol/L) as reported by the subject
Exclusion Criteria:
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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03791567
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University of Illinois at Chicago Medical Center
Chicago, Illinois, United States, 60612
CellTrans Inc.
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Principal Investigator:
Jose Oberholzer, MD
University of Illinois at Chicago
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Qi M, Kinzer K, Danielson KK, Martellotto J, Barbaro B, Wang Y, Bui JT, Gaba RC, Knuttinen G, Garcia-Roca R, Tzvetanov I, Heitman A, Davis M, McGarrigle JJ, Benedetti E, Oberholzer J. Five-year follow-up of patients with type 1 diabetes transplanted with allogeneic islets: the UIC experience. Acta Diabetol. 2014 Oct;51(5):833-43. doi: 10.1007/s00592-014-0627-6. Epub 2014 Jul 18.
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Responsible Party:
Jose Oberholzer, Adjunct Professor of Surgery, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT03791567 Â Â
Other Study ID Numbers:
EA IND11807-2007-0330
First Posted:
January 2, 2019 Â Â Key Record Dates
Last Update Posted:
August 29, 2023
Last Verified:
August 2023
Keywords provided by Jose Oberholzer, University of Illinois at Chicago:
Type 1Type 1 Diabetes MellitusIslets of Langerhans TransplantationAllogeneic Islet transplantation
Additional relevant MeSH terms:
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Diabetes MellitusDiabetes Mellitus, Type 1Glucose Metabolism DisordersMetabolic Diseases
Endocrine System DiseasesAutoimmune DiseasesImmune System Diseases
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
