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NCT03513939 · ClinicalTrials.gov registry record · Phase 1
A Safety, Tolerability and Efficacy Study of Sernova's Cell Pouch™ for Clinical Islet Transplantation
A Phase 1 study of Type 1 Diabetes Mellitus, sponsored by Sernova Biotherapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT03513939: Active Phase 1 study of Type 1 Diabetes Mellitus, sponsored by Sernova Biotherapeutics.
NCT03513939 is a Phase 1 study of Type 1 Diabetes Mellitus that is active but no longer recruiting, run by Sernova Biotherapeutics. The registered enrollment target is 17 participants, below the 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03513939, a Phase 1 study of Type 1 Diabetes Mellitus, is active but no longer recruiting, sponsored by Sernova Biotherapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study Summary
The Cell Pouch™ is a novel implantable device, that is transplanted with therapeutic cells such as insulin producing islets. This combination product is designed for the treatment of Type 1 Diabetes Mellitus (T1D) with hypoglycemia unawareness and a history of severe hypoglycemic episodes. Upon implantation, the Cell Pouch is designed to form a natural environment, rich in tissue and microvessels for the transplant and function of therapeutic cells. The Cell Pouch is designed as a scaffold made of non-degradable polymers, formed into small cylindrical chambers which, when implanted against the abdominal muscle, becomes incorporated with vascularized tissue to the circumference of removable plugs within as early as two weeks as demonstrated in preclinical studies. After the tissue incorporation, the plugs are removed, leaving fully formed tissue chambers with central void spaces for the transplantation of therapeutic cells including Islets of Langerhans (islets). Tissue integration within and around the Cell Pouch forms a natural environment, rich in microvessels that allows the transplanted islets to engraft, resulting in a functional biohybrid organ. It is believed this engraftment will enable long-term survival and function of transplanted islets. This study aims to demonstrate the safety and tolerability of islet transplantation into the Cell Pouch for the treatment of T1D in subjects with hypoglycemia unawareness and a history of severe hypoglycemic episodes. The study also aims to establish islet release criteria that accurately characterize the islet product and are predictive of clinical transplant outcomes into the Cell Pouch, which will be demonstrated through defined efficacy measures.
Primary Outcome
Safety will be assessed by evaluating the incidence and severity of adverse events (AEs) determined to be probable or highly probable to the Cell Pouch following initial Cell Pouch implantation, at the time of islet transplantation, and following islet transplantation, and throughout the study up to 365 days ±14 days post-islet transplantation
Conditions Studied
Interventions
- COMBINATION_PRODUCT Sernova Cell Pouch
Study Locations (1)
Illinois
- University of Chicago Medical Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2019-02-07 |
| Est. Completion | 2026-10 |
| Phase | Phase 1 |
What the registry record for NCT03513939 still lists
NCT03513939 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 1 intervention - of which Sernova Cell Pouch is the first listed.
NCT03513939 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT03513939 about?
NCT03513939 is a clinical study titled "A Safety, Tolerability and Efficacy Study of Sernova's Cell Pouch™ for Clinical Islet Transplantation". The Cell Pouch™ is a novel implantable device, that is transplanted with therapeutic cells such as insulin producing islets. This combination product is designed for the treatment of Type 1 Diabetes Mellitus (T1D) with hypoglycemia unawareness and a history of severe hypoglycemic episodes. Upon impl...
What is the current status of trial NCT03513939?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2019-02-07. Estimated completion is 2026-10.
What conditions does trial NCT03513939 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.
What interventions are being tested in trial NCT03513939?
The interventions under investigation include: Sernova Cell Pouch (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03513939?
This trial is sponsored by Sernova Biotherapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03513939 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03513939's enrollment target sits among peer trials
17 96th of 112 higher than 17 of 112 other Type 1 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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