Diabetes mellitus type 1 and succesful renal transplant MedDRA version: 9.1 Level: LLT Classification code 10012638 Term: Diabetes with renal manifestations MedDRA version: 9.1 Level: LLT Classification code 10038533 Term: Renal transplant
Conditions
Interventions
Product Name: Autologous CD34+ stem cell subset
Pharmaceutical Form:
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female patients aged from 16 to 65 years of age Patient with Type I diabetes mellitus plus: Successful previous kidney transplant. Good kidney allograft function /no episodes of rejection for at least one year post-transplant Not taking steroids as part of standard immuno-suppression Has a WHO performance score of less than 2 Has a life expectancy of at least 3 months Ability to give written consent Women of childbearing potential may be included, but must use a reliable and appropriate contraceptive method Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients below the age of 16 or above the age of 65 years Patients with chronic pancreatitis and poor exocrine pancreatic function Pregnant or lactating women Patients with recent recurrent GI bleeding or spontaneous bacterial peritonitis Patients with evidence of HIV or other life threatening infection Patients unable to give written consent Patients with a history of hypersensitivity to G-CSF Patients who have been included in any other clinical trial within the previous month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerance of a high dose of autologous expanded progeny of adult CD34+ stem cell subset (InsulinCytes) when introduced into either the body or tail of the pancreas. ;Secondary Objective: To assess improvement in endocrine pancreatic function as measured by serological and biochemical analysis and determine any symptomatic improvements as they are reported by the patients.;Primary end point(s): To assess the safety and tolerance of a high dose of autologous expanded progeny of adult CD34+ stem cell subset (InsulinCytes) when introduced into either the body or tail of the pancreas. | — |
Countries
United Kingdom
Outcome results
None listed