RecruitingEarly Phase 1NCT06239636

First-in-human Safety Study of Hypoimmune Pancreatic Islet Transplantation in Adult Subjects With Type 1 Diabetes

Sponsor

Per-Ola Carlsson

Enrollment

2 participants

Start Date

Mar 8, 2024

Study Type

INTERVENTIONAL

Conditions

Type1diabetes

Summary

The current study tests the hypothesis whether genetically modified Langerhans islet cells containing insulin-producing cells from a deceased organ donor can 1. be transplanted safely and 2. help to regain insulin production in individuals with type 1 diabetes without need in simultaneous treatment with immunosuppressive medicines. The study is an open, one-armed study where adult subjects with longstanding type 1 diabetes will receive transplantation of Langerhans islet cells (25 000 000-80 000 000) into forearm muscle. Both subjects receive active treatment. Safety is monitored with frquent follow-up visits over a year, including medical examinations, blood tests and MRI scans. Insluin producing cell function is monitored with blood samples and continuous glucose measurement. Main objective is to to investigate the safety of an intramuscular transplantation of genetically modified allogeneic human islets (study product UP421) in adult subjects diagnosed with type 1 diabetes. Secondary objectives are to study changes in beta-cell function, metabolic control and immunological response to pancreatic islets during the first year following treatment.

Eligibility

Min Age: 30 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is the first human test of a new type of pancreatic islet transplant for people with type 1 diabetes. Normally, transplanted islets (insulin-producing cells) require life-long anti-rejection drugs. This study uses specially engineered "hypoimmune" cells designed to avoid rejection without those medications, which may make transplantation safer and more accessible. **You may be eligible if...** - You have had type 1 diabetes for 5 or more years, diagnosed before age 18 - You are between 30 and 45 years old - Your HbA1c (blood sugar control measure) has been 70 mmol/mol or higher over the past 5 years - You are on intensive insulin therapy (insulin pump or 3+ injections per day) and using continuous glucose monitoring - Your body weight is under 80 kg - You no longer produce your own insulin (C-peptide negative) - You test positive for certain diabetes antibodies (GAD or IA2) **You may NOT be eligible if...** - You do not meet the above diabetes criteria - You are not in the specified age or weight range - You are pregnant or unwilling to use contraception for one year after treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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