Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 1 Diabetes | Combination Product: Co-transplantation of PTG with pancreatic islets | Phase 1 Phase 2 |
Single-center, open label, non-randomized safety and efficacy trial to evaluate co-transplantation of allogeneic parathyroid glands (PTG) with adult pancreatic islets (both PTG and pancreatic islets obtained from same deceased donor) in people with Type 1 diabetes in the intramuscular (IM) site with stable function of liver or kidney allografts on chronic immunosuppression.
A total of 8 patients will be enrolled in the study and followed for a minimum of 1 year up to 2 years after the last islet transplant, depending on enrollment date.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 8 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pancreatic Islets and Parathyroid Gland Co-transplantation for Treatment of Diabetes in the Intra-Muscular Site |
Actual Study Start Date : | July 1, 2019 |
Estimated Primary Completion Date : | January 30, 2023 |
Estimated Study Completion Date : | June 30, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: PTG with adult pancreatic islet co-transplantation
People with Type 1 (c-peptide negative) diabetes with stable kidney or liver allografts on chronic immunosuppression who receive study intervention, which is co-transplantation of allogeneic parathyroid (PTG) with adult pancreatic islets in people with Type 1 diabetes in the intramuscular (IM) site
|
Combination Product: Co-transplantation of PTG with pancreatic islets
Co-transplantation of allogeneic parathyroid glands (PTG) with adult pancreatic islets (both PTG and pancreatic islets obtained from same deceased donor) in people with Type 1 diabetes in the intramuscular (IM) site with stable function of liver or kidney allografts on chronic immunosuppression
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Severe co-existing cardiac disease, characterized by any one of these conditions:
Contact: Patricia Brennan, RN, PhD | 415-476-3229 | Patricia.Brennan@ucsf.edu | |
Contact: Rodney Rogers | 415-514-6454 | Rodney.Rogers@ucsf.edu |
United States, California | |
University of California | Recruiting |
San Francisco, California, United States, 94143 | |
Contact: Patricia Brennan, RN, PhD 415-476-3229 Patricia.Brennan@ucsf.edu |
Principal Investigator: | Peter Stock, MD, PhD | University of California, San Francisco |
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | May 24, 2019 | ||||||||
First Posted Date ICMJE | June 6, 2019 | ||||||||
Last Update Posted Date | June 4, 2021 | ||||||||
Actual Study Start Date ICMJE | July 1, 2019 | ||||||||
Estimated Primary Completion Date | January 30, 2023 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
|
||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
|
||||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Pancreatic Islets and Parathyroid Gland Co-transplantation for Treatment of Type 1 Diabetes | ||||||||
Official Title ICMJE | Pancreatic Islets and Parathyroid Gland Co-transplantation for Treatment of Diabetes in the Intra-Muscular Site | ||||||||
Brief Summary | The primary objective is to test the hypothesis that co-transplantation of allogeneic PTG with adult pancreatic islets (derived from same deceased donor) in the IM site in people with Type 1 diabetes with functioning kidney and/or liver transplants is safe, allows islet engraftment, and leads to insulin independence. | ||||||||
Detailed Description |
Single-center, open label, non-randomized safety and efficacy trial to evaluate co-transplantation of allogeneic parathyroid glands (PTG) with adult pancreatic islets (both PTG and pancreatic islets obtained from same deceased donor) in people with Type 1 diabetes in the intramuscular (IM) site with stable function of liver or kidney allografts on chronic immunosuppression. A total of 8 patients will be enrolled in the study and followed for a minimum of 1 year up to 2 years after the last islet transplant, depending on enrollment date. |
||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 1 Phase 2 |
||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||||
Condition ICMJE | Type 1 Diabetes | ||||||||
Intervention ICMJE | Combination Product: Co-transplantation of PTG with pancreatic islets
Co-transplantation of allogeneic parathyroid glands (PTG) with adult pancreatic islets (both PTG and pancreatic islets obtained from same deceased donor) in people with Type 1 diabetes in the intramuscular (IM) site with stable function of liver or kidney allografts on chronic immunosuppression
|
||||||||
Study Arms ICMJE | Experimental: PTG with adult pancreatic islet co-transplantation
People with Type 1 (c-peptide negative) diabetes with stable kidney or liver allografts on chronic immunosuppression who receive study intervention, which is co-transplantation of allogeneic parathyroid (PTG) with adult pancreatic islets in people with Type 1 diabetes in the intramuscular (IM) site
Intervention: Combination Product: Co-transplantation of PTG with pancreatic islets
|
||||||||
Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
8 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | June 30, 2023 | ||||||||
Estimated Primary Completion Date | January 30, 2023 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
Sex/Gender ICMJE |
|
||||||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
|
||||||||
Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03977662 | ||||||||
Other Study ID Numbers ICMJE | 18-26725 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
|
||||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||||
Responsible Party | Peter Stock, University of California, San Francisco | ||||||||
Study Sponsor ICMJE | Peter Stock | ||||||||
Collaborators ICMJE | California Institute for Regenerative Medicine (CIRM) | ||||||||
Investigators ICMJE |
|
||||||||
PRS Account | University of California, San Francisco | ||||||||
Verification Date | June 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |