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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00788827
Recruitment Status : Completed
First Posted : November 11, 2008
Results First Posted : November 18, 2019
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Brief Summary:
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 or disease Intervention/treatment Phase
Type 1 Diabetes Type 2 Diabetes Biological: Autologous CD34+ stem cells Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Autologous stem cells
Masking: None (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
Actual Study Start Date : November 2008
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Autologous CD34+ stem cells
Up to 5 x 10 log 8 of autologous stem cells on a single occasion
Biological: Autologous CD34+ stem cells
Up to 5 x 10 log 8 of autologous stem cells on a single occasion




Primary Outcome Measures :
  1. Number of Participants Who Experienced Adverse Events [ Time Frame: 14 days ]
    Safety will be evaluated in terms of adverse events graded according to CTCTAE toxicity criteria and laboratory test results. All adverse events will also be graded for relationship to treatment and as expected and unexpected.


Secondary Outcome Measures :
  1. Hba1C Data of Pre and Post Stem Cell Infusion [ Time Frame: 12 weeks ]
    Mean HbA1c laboratory measurements pre and post stem cell infusion

  2. Insulin Level [ Time Frame: 12 weeks ]
    Mean insulin requirement was calculated for each participant pre and post stem cell infusion

  3. Amylase Level [ Time Frame: 12 weeks ]
    Each participant had mean amylase data analysed to give a pre and post mean result

  4. Serum Creatinine [ Time Frame: 12 weeks ]
    Each participant had serum creatinine analysis pre and post stem cell infusion to give mean result



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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): NCT00788827


Locations
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United Kingdom
Imperial College NHS Healthcare Trust, Hammersmith Hospital
London, United Kingdom, W12 0HS
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Charles Pusey, MD Imperial College London

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00788827    
Other Study ID Numbers: HHSC 005
CRO0472 ( Other Identifier: Imperial College London )
First Posted: November 11, 2008    Key Record Dates
Results First Posted: November 18, 2019
Last Update Posted: November 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
diabetes type I
diabetes type 2
renal transplant
stem cells
successful renal transplant
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases