Type 1 Diabetes
Conditions
Keywords
Insulin Dependent
Brief summary
The overall objective of this pilot project is to evaluate the safety and efficacy of the gastric submucosal space as a novel site for clinical islet transplantation. The site has several physiologic attributes that may improve the outcomes of islet transplantation compared with the conventional intraportal transplant site.
Detailed description
The overall objective of this pilot project is to evaluate the safety and efficacy of the gastric submucosal space as a novel site for clinical islet transplantation. Safety will be evaluated by the monitoring of side effects such as post procedural GI complications, frequency of hypo and hyperglycemic events, and immunosuppression side effects. Efficacy will be determined by accepted measures including insulin independence, long term glucose control, and reduction/elimination of hypoglycemic events. The site has several physiologic attributes that may improve the outcomes of islet transplantation compared with the conventional intraportal transplant site.
Interventions
BIOLOGICALIsolated Human Pancreatic Islets
Sponsors
Andrew Posselt
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: 1. Primary islet allotransplant 2. Type I diabetes mellitus for a minimum of 5 years 3. One or more of the following signs or symptoms despite intensive efforts made in close cooperation with their diabetic care team: * Metabolic lability/instability characterized by hypoglycemia or ketoacidosis (\>2 hospital admissions in the previous year), erratic glucose profiles (MAGE\>120 mg/dL), or disruption in lifestyle of danger to life, self or others * Reduced awareness of hypoglycemia or \>1 episode in the last 1.5 years of severe hypoglycemia * Persistently poor glucose control (as defined by HgbA1c\>10% at the end of six months of Intensive management efforts with the diabetes care team) * Progressive secondary complications as defined by (i) a new proliferative retinopathy or clinically significant macular edema or therapy with photocoagulation during the last year; or (ii) symptomatic autonomic neuropathy (as defined by postural hypotension or neuropathic bladder) 4. Age 18 and older 5. Patients who have a renal transplant must have received their transplant at least 3 months previously and must have stable renal function (see
Exclusion criteria
below) 6. Must be able to give written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Six months | Hypo- and Hyper-glycemia limits for blood glucose related risks; during procedure, abdominal pain, duodenal hemorrhage, and duodenal perforation post-procedure, fever, cytokine release syndrome (to the thymoglobulin), immunosuppression related issues |
Countries
United States
Outcome results
None listed