Who is eligible for clinical trial NCT03513939?

Participants must meet the protocol's inclusion criteria for Type 1 Diabetes Mellitus. The stated age range is 18 Years to 65 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT03513939 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-02-23

A Safety, Tolerability and Efficacy Study of Sernova's Cell Pouch™ for Clinical Islet Transplantation (NCT03513939)

🔵 Active, Not Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: Sernova Biotherapeutics Inc.

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (40 items).

Location: University of Chicago Medical Center — Chicago, Illinois

Age range: 18 Years to 65 Years

🧪 Interventions in This Study

Sernova Cell Pouch (COMBINATION_PRODUCT)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Male and female patients 18 to 65 years of age.
Ability to provide written informed consent.
Mentally stable and able to comply with the procedures of the study protocol.
Clinical history compatible with Type 1 Diabetes Mellitus (T1DM) with onset of disease at \<40 years of age, insulin-dependence for ≥5 years at the time of consent, and a sum of patient age and insulin dependent diabetes duration of ≥28.
Absent stimulated c-peptide (\<0.3 ng/mL) in response to a mixed meal tolerance test (MMTT; measured during the 4 hour test).
Involvement in intensive diabetes management defined as self-monitoring of glucose values no less than a mean of three times each day averaged over each week and by the administration of three or more insulin injections each day or insulin pump therapy. Such management must be under the direction of an endocrinologist, diabetologist, or diabetes specialist with at least 3 clinical evaluations during the 12 months prior to study consent.
At least one episode of severe hypoglycemia in the 12 months prior to study consent.
Reduced awareness of hypoglycemia. More information about this criterion, including specific definitions of hypoglycemia unawareness, is in the protocol.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Body mass index (BMI) \>30 kg/m2
Insulin requirement \>1.0 IU/kg/day
Glycated Haemoglobin (HbAlc) \>13%.
Untreated proliferative diabetic retinopathy.
Blood Pressure: Systolic blood pressure (SBP) \>160 mmHg or Diastolic Blood Pressure (DBP) \>100 mmHg.
Measured glomerular filtration rate \<70 mL/min/1.73m2 (More information about this criterion is in the protocol
Presence or history of macroalbuminuria (\>300 mg/g creatinine).
Presence or history of panel-reactive anti-HLA antibodies \>30%
For female subjects of child bearing potential: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 4 months after discontinuation. For male subjects: intent to procreate during the duration of the study or within 4 months after discontinuation or unwillingness to use effective measures of contraception. More information about this criterion is in the protocol.
Presence or history of active infection including hepatitis B, hepatitis C, HIV, or tuberculosis (TB). Subjects with laboratory evidence of active infection are excluded even in the absence of clinical evidence of active infection.
Patients with negative screen for Epstein Barr Virus by Immunoglobulin G (IgG) determination. More information about this criterion is in the protocol,

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

University of Chicago Medical Center — Chicago, Illinois

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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Explore by condition: All Type 1 Diabetes Mellitus clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Review the official NIH record below to find the coordinating site.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗