Allotransplantation for patients with T1DM
OPEN ENROLLMENT
Multicenter, Phase 1/2 Pilot Study of Safety and Efficacy Assessment of Tegoprubart and Calcineurin Inhibitors- Free Immunosuppression Therapy for Pancreatic Islets Transplantation in Patients With T1DM and Chronic Kidney Disease
Funded by Breakthrough T1D,
Tegoprubart provided by Eledon Pharmaceutical
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This is a clinical study, where patient is being treated according to the study protocol approved by Institutional Review Board (Ethics Committee) at University of Chicago as well as the FDA.
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Two new investigational complements will be tested:
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Human pancreatic islets and,
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Tegoprubart (Eledon)- new anti-rejection (immunosuppression) medication
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None of them is approved by FDA to clinical used as a standard of care.
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The study is designed for patients with type 1 diabetes and with severe problems in managing low and/or high blood glucose despite their best efforts and using the best insulin delivery and blood glucose monitoring technology as well as having a chronic kidney disease.
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Human pancreatic islets are isolated from deceased donor pancreas and infused in special solution through a small catheter into patient liver. The catheter is placed under local anesthesia by interventional radiologist.
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Patient remains in the hospital for 5 days during islet transplant procedure and in Chicago a week after discharge from the hospital.
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Tegoprubart is infused into patient vein on forearm over 1 hour. Infusion takes place during the hospital stay and then after one, two, three and four weeks after the transplant. After that patient still needs to come to University of Chicago for Tegoprubart infusions every three weeks for as long as participates in the study.
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Cost of travel will be reimbursed.
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Patient participation in this study is expected to be 5 years.
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More information you can find on www.clinicaltrials.gov , click HERE.
If you are interested in participation in the study please click Enroll Here (above) and follow the instructions.

