OPF-310 for Type 1 Diabetes

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Otsuka Pharmaceutical Factory, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?This study is First In Human study for Encapsulated Porcine Islet Cells for Xenotransplantation (OPF-310). The purpose of this study to assess the safety, tolerability, and efficacy of OPF-310 transplantation and to define the recommended Phase 2 dose (RP2D) in adult subjects with unstable Type 1 Diabetes Mellitus (T1DM) and a level 3 (severe) hypoglycemic episode at least three times within the 1 year prior to enrollment despite treatment with a closed loop system (CLS) for at least 6 months.

Eligibility Criteria

This trial is for adults aged 35-65 with unstable Type 1 Diabetes Mellitus, who've had severe low blood sugar episodes despite using advanced glucose monitoring and insulin pumps. Participants must have a history of diabetes for at least 5 years, an HbA1c level between 7.5% and 9%, very low or undetectable C-peptide levels, and agree to lifetime follow-up.

Inclusion Criteria

I can sign and understand the consent form.

I am using birth control as required by local laws for clinical study participants.

I agree to lifetime follow-up after my transplant.

+6 more

Participant Groups

The study tests the safety and effectiveness of OPF-310, encapsulated pig-derived pancreatic cells transplanted into humans with Type 1 Diabetes to improve blood sugar control. It aims to determine the proper dose for Phase 2 trials in patients with severe hypoglycemia history.

1Treatment groups

Experimental Treatment

Group I: OPF-310Experimental Treatment1 Intervention

13 patients will be transplanted OPF-310.