A Phase I/II Study of the Safety and Efficacy of Sernova's Cell PouchTM for Therapeutic Islet Transplantation
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|ClinicalTrials.gov Identifier: NCT01652911|
Recruitment Status : Terminated
First Posted : July 30, 2012
Last Update Posted : May 11, 2022
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This is an open-label, single arm, non-randomized safety and efficacy study, where participants with Type-1 diabetes will receive the Sernova Cell Pouch™ implanted in the subcutaneous site, two to approximately twelve weeks prior to transplantation of islets into the Cell Pouch™.
The primary objective of this study is to assess the safety of the Sernova Cell Pouch™ in adult participants with Type-1 diabetes receiving islet transplantation for the first time.
Secondary objectives are the following:
- To determine the proportion of subjects implanted with the Cell Pouch™ and transplanted with islets into the Cell Pouch™ who achieve and maintain insulin independence after islet transplantation.
- To obtain preliminary data on the efficacy of the Cell Pouch™ to maintain adequate immunological protection against both allo- and autoimmunity of islet transplant recipients.
- To determine through retrospective analysis comparative metabolic function and engraftment efficiency using patients undergoing standard intraportal islet transplantation under the current alemtuzumab standard of care protocol.
|Condition or disease||Intervention/treatment||Phase|
|Type I Diabetes||Device: Sernova Cell Pouch||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of the Safety and Efficacy of Sernova's Cell PouchTM for Therapeutic Islet Transplantation|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
Experimental: Cell Pouch
Participants with Type-1 diabetes will receive the Sernova Cell Pouch™ implanted in the subcutaneous site, two to approximately twelve weeks prior to transplantation of islets into the Cell Pouch™.
Device: Sernova Cell Pouch
The Cell Pouch™ is an implantable medical device for transplantation of donor islets for Type-1 diabetes as an alternative to the current standard of care using intraportal delivery of islets.
- To assess the safety of the Sernova Cell Pouch™ in adult participants with Type-1 diabetes receiving islet transplantation for the first time. [ Time Frame: 3 years post-initial Cell Pouch™ implant. ]A tracking log will document adverse events with grading classification as per protocol. For the primary objective endpoint, safety will be assessed following initial Cell Pouch implantation, at the time of islet transplantation, and approximately one month following the initial islet transplantation. Safety will further be assessed at approximately three, six, nine and twelve months and then yearly thereafter.
- To determine the proportion of subjects implanted with the Cell Pouch™ and transplanted with islets into the Cell Pouch™ who achieve insulin independence after islet transplantation. [ Time Frame: 3 years post-initial Cell Pouch™ implant. ]The proportion of study participants achieving and maintaining insulin independence (c-peptide, HbA1c level) with good glycemic control (blood sugar measurement) at 1, 3, 6 and 12 months and yearly thereafter.
- To obtain preliminary data on the efficacy of the Cell Pouch™. [ Time Frame: 3 years post-initial CellPouch™ ]The efficacy analysis will compare observed proportion of subjects who become insulin independent at the end of month 3 following the completed islet transplant. The outcomes will also be analyzed at 1, 6 and 12 months and then yearly thereafter.
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|Ages Eligible for Study:||18 Years to 68 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
To be eligible the participant must have had T1DM for more than 5 years, complicated by at least 1 of the following situations that persist despite intensive insulin management efforts:
- Reduced awareness of hypoglycemia, as defined by the absence of adequate autonomic symptoms at plasma glucose levels < 3.0 mmol/L, indicated by, 2 or more episodes of severe hypoglycemia requiring third party assistance within 12 months, a Clarke score ≥4, HYPO score ≥1,000, lability index (LI) ≥400 or combined Hypo/LI >400/300
- Metabolic instability, characterized by erratic blood glucose levels that interfere with daily activities and or 2 or more hospital visits for diabetic ketoacidosis over the last 12 months.
Participants must be capable of understanding the purpose and risks of the study and must sign a statement of informed consent.
- Severe co-existing cardiac disease, characterized by any one of these conditions: (a) recent myocardial infarction (within past 6 months); (b) left ventricular ejection fraction <30%; or (c) evidence of ischemia on functional cardiac exam.
- Active alcohol or substance abuse, to include cigarette smoking (must be abstinent for 6 months prior to transplant).
- Psychiatric disorder making the subject not a suitable candidate for transplantation, (e.g., schizophrenia, bipolar disorder, or major depression that is unstable or uncontrolled on current medication).
- History of non-adherence to prescribed regimens.
- Active infection including Hepatitis C, Hepatitis B, HIV, TB (subjects with a positive PPD performed within one year of enrollment, and no history of adequate chemoprophylaxis).
- Any history of or current malignancies except squamous or basal skin cancer.
- BMI > 35 kg/m2 at screening visit.
- Age less than 18 or greater than 68 years.
- Measured glomerular filtration rate (GFR) <60 mL/min/1.73 m2.
- Presence or history of macroalbuminuria (>300 mg/g creatinine).
- Clinical suspicion of nephritic (hematuria, active urinary sediment) or rapidly progressing renal impairment (e.g. Increase in serum creatinine of 25% within the last 3-6 months).
- Baseline Hb < 105g/L in women, or < 120 g/L in men.
- Baseline screening liver function tests outside of normal range, with the exception of uncomplicated Gilbert's Syndrome. An initial LFT panel with any values >1.5 times the upper limit of normal (ULN) will exclude a patient without a re-test; a re test for any values between ULN and 1.5 times ULN should be made, and if the values remain elevated above normal limits, the patient will be excluded.
- Untreated proliferative retinopathy.
- Positive pregnancy test, intent for future pregnancy or male subjects' intent to procreate, failure to follow effective contraceptive measures, or presently breast feeding.
- Previous transplant or evidence of significant sensitization on PRA (at the discretion of the investigator).
- Insulin requirement >1.0 U/kg/day
- HbA1C >12%.
- Uncontrolled hyperlipidemia [fasting LDL cholesterol > 3.4 mmol/L, treated or untreated; and/or fasting triglycerides > 2.3 mmol/L].
- Under treatment for a medical condition requiring chronic use of steroids.
- Use of coumadin or other anticoagulant therapy (except aspirin) or subject with PT INR > 1.5.
- Untreated Celiac disease.
- Patients with Graves disease will be excluded unless previously adequately treated with radioiodine ablative therapy.
- Any medical condition that, in the opinion of the clinical investigator, will interfere with the safe participation in the trial.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01652911
|University of Alberta - Clinical Islet Transplant Program|
|Edmonton, Alberta, Canada, T6G 2C8|
|Principal Investigator:||James Shapiro, MD, PhD||University of Alberta|
|Responsible Party:||University of Alberta|
|Other Study ID Numbers:||
|First Posted:||July 30, 2012 Key Record Dates|
|Last Update Posted:||May 11, 2022|
|Last Verified:||July 2016|
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Endocrine System Diseases
Immune System Diseases