Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06575426
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
A Study to Investigate Safety and Effectiveness of Pancreatic Cells Derived From Pigs OPF-310 in Patients With Type 1 Diabetes Mellitus
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase IIIa Single Site Open-Label Ascending Dose Study to Evaluate the Safety and Efficacy of OPF-310 Encapsulated Porcine Islet Cells for Xenotransplantation in Subjects With Type 1 Diabetes Mellitus
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None