Autologous Adult Stem Cells to Patients With Type 1 Diabetes and a Successful Renal Transplant

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Imperial College London.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00788827
First received: November 10, 2008
Last updated: July 11, 2011
Last verified: July 2011
  Purpose

This is a phase I study to assess the safety and tolerability of infusing expanded stem cells into the pancreas of patients with type I diabetes and a successful renal transplant. The stem cells used in this study occur naturally in the body and are collected from each recipient by a procedure called leukapheresis. The cells are then expanded and differentiated into insulin-like cells in a sterile suite before being injected into the body or tail of the pancreas of the recipient.


Condition Intervention Phase
Type 1 Diabetes
Type 2 Diabetes
Biological: Autologous CD34+ stem cells
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Safety and Tolerability Study Following the Infusion of Autologous Expanded Progeny of an Adult CD34+ Stem Cell Subset (InsulinCytes) to Patients With Type I Diabetes Mellitus and a Successful Renal Transplant

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Safety will be evaluated in terms of adverse events graded according to CTC toxicity criteria and laboratory test results. All adverse events will also be graded for relationship to treatment and as expected and unexpected. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: November 2008
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Autologous CD34+ stem cells
    Up to 5 x 10 log 8 of autologous stem cells on a single occasion
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients aged from 16 to 65 years of age
  • Patient with Type I or Type 2 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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00788827

Contacts
Contact: Charles Pusey, MD +44 20 8383 2308 c.pusey@imperial.ac.uk
Contact: Vassilios Papalois, MD +44 20 8383 2308 vassilios.Papalois@imperial.nhs.uk

Locations
United Kingdom
Imperial College NHS Healthcare Trust, Hammersmith Hospital Recruiting
London, United Kingdom, W12 0HS
Contact: Charles Pusey, MD    +44 20 8383 2308    c.pusey@imperial.ac.uk   
Contact: Vassilios Pusey, MD       Vassilios.Papalois@imperial.nhs.uk   
Sub-Investigator: Vassilios Papalois, MD         
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Charles Pusey, MD Imperial College London
  More Information

No publications provided

Responsible Party: Professor Charles Pusey, Imperial College London
ClinicalTrials.gov Identifier: NCT00788827     History of Changes
Other Study ID Numbers: HHSC 005, EudraCT 2006-002328-40
Study First Received: November 10, 2008
Last Updated: July 11, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Imperial College London:
diabetes type I
diabetes type 2
renal transplant
stem cells
successful renal transplant

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014