A phase I safety and tolerability study of infusing the autologous progeny of an adult CD34+ subset into patients with type I diabetes mellitus and a successful renal transplant. - Stem cell and diabetes study

Phase 1

• Conditions: 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

• Registration Number: EUCTR2006-002328-40-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-07-23
• Study Completion: 2013-05-31
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 7

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.