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Type 1 Diabetes MellitusNCT03791567

Islet Transplantation in Type I Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol

A study testing Donislecel (allogeneic islets of Langerhans for transplant) in people with Type 1 Diabetes Mellitus, run by CellTrans Inc. at 1 site in United States.

Approved For Marketing

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Donislecel (allogeneic islets of Langerhans for transplant)
How many people
Not given
Where
1 siteUnited States
Study dates
Start not givento not given
Phase
Expanded access
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Diagnosis of co-existing cardiac disease characterized by any one of these conditions:
  • Recent myocardial infarction (within past six months), or
  • Angiographic evidence of non-correctable coronary artery disease, or
  • Evidence of ischemia on functional cardiac exam (with a stress echo test recommended
  • for subjects with a history of ischemic disease).
  • Heart failure > New York Heart Assoication (NYHA) II
Show all 41Show fewer
  • Active alcohol or substance abuse-includes cigarette smoking (must be abstinent for six months). Active alcohol abuse should be considered using the current National Institute on Alcohol Abuse and Alcoholism (NIAAA) definitions.
  • Psychiatric disorder making the subject not a suitable candidate for transplantation, e.g., schizophrenia, bipolar disorder, or major depression that is unstable or uncontrolled on current medication. (A psychological or psychiatric consultation is required only if considered necessary by some current indication or history.)
  • History of non-adherence to prescribed regimens
  • Active infection including hepatitis C, hepatitis B, HIV
  • TB (by history or currently infected as evidenced by a positive QuantiFERON® -TB Gold test or under treatment for suspected TB)
  • Any history of malignancies except squamous or basal skin cancer. Any subject found to have squamous or basal cancer is required to have it removed prior to transplant.
  • History of stroke within the past 6 months
  • Body Mass Index (BMI) > 27 kg/m2.
  • C-peptide response to glucagon stimulation (1 mg i.v.) (any C-peptide ≥ 0.3 ng/mL)
  • Inability to provide informed consent
  • Age less than 18 or greater than 65 years
  • Creatinine clearance < 80 mL/min/1.73 m2 by 24-hour urine collection. If corrected creatinine clearance is < 80 and serum creatinine is < 1.2 mg/dl, then a nuclear renal scan is required to determine gomerular filtration rate.
  • Serum creatinine consistently > 1.5 mg/dL
  • Macroalbuminuria (urinary albumin excretion rate > 300 mg/24h)
  • Baseline Hb < 12 gm/dL in women or < 13 gm/dL in men
  • Baseline liver function tests (LFT) outside of normal range (An initial LFT test panel with any values > 1.5 times normal upper limits will exclude a subject without a re-test. A re-test for any values between normal and 1.5 times normal should be made, and if the values remain elevated above normal limits, the subject will be excluded.)
  • Untreated proliferative retinopathy
  • Positive pregnancy test, intent for future pregnancy, or male subjects' intent to procreate, unwilling to follow effective contraceptive measures, or presently breast-feeding
  • Insulin requirement > 0.7 IU/kg/day
  • HbA1c > 12%
  • Hyperlipidemia (fasting LDL cholesterol > 130 mg/dL, treated or untreated; and/or fasting triglycerides > 200 mg/dL)
  • Under treatment for a medical condition requiring chronic use of steroids other than a previous organ transplant
  • Use of coumadin or other antiplatelet or anticoagulant therapy, or subject with PT INR > 1.5. Low dose aspirin is allowed after transplantation.
  • History of Factor V deficiency
  • Currently smoking tobacco
  • Addison's disease
  • Allergy to radiographic contrast material
  • Symptomatic cholecystolithiasis
  • Acute or chronic pancreatitis
  • Symptomatic peptic ulcer disease
  • Severe unremitting diarrhea, vomiting, or other gastrointestinal disorders that could interfere with the ability to absorb oral medications
  • Treatment with antidiabetic medication other than insulin within 4 weeks of enrollment
  • Use of any study medication within 4 weeks of enrollment
  • Received live attenuated vaccine(s) within 2 months of enrollment
  • Any medical condition that, in the opinion of the investigator, might interfere with safe participation

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Illinois at Chicago Medical Center

    Chicago, Illinois, 60612

Other trials in United States

About this study

Official title: Expanded Access to Donislecel for Treatment Use

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.

Read the 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.

Being tested
Donislecel (allogeneic islets of Langerhans for transplant)
Keywords
Type 1, Type 1 Diabetes Mellitus, Islets of Langerhans Transplantation, Allogeneic Islet transplantation
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Donislecel (allogeneic islets of Langerhans for transplant)Biological

    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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Expanded access
IDs, dates and publications
ClinicalTrials.gov ID
NCT03791567
Sponsor's protocol ID
EA IND11807-2007-0330
Status last verified
Oct 2024
First submitted
31 Dec 2018
Last updated
22 Oct 2024
Results posted
No

Publications

  • 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.

    PubMed 25034311

  • Williams J, Jacus N, Kavalackal K, Danielson KK, Monson RS, Wang Y, Oberholzer J. Over ten-year insulin independence following single allogeneic islet transplant without T-cell depleting antibody induction. Islets. 2018;10(4):168-174. doi: 10.1080/19382014.2018.1451281. Epub 2018 Jul 19.

    PubMed 30024826

Questions about this trial

What is this clinical trial studying?

A study testing Donislecel (allogeneic islets of Langerhans for transplant) in people with Type 1 Diabetes Mellitus, run by CellTrans Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03791567, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.

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