Autologous Adult Stem Cells to Patients With Type 1 Diabetes and a Successful Renal Transplant
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
2 other identifiers
interventional
7
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Nov 2008
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 10, 2008
CompletedFirst Posted
Study publicly available on registry
November 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
November 18, 2019
CompletedNovember 18, 2019
October 1, 2019
4.5 years
November 10, 2008
July 26, 2019
October 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Who Experienced Adverse Events
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.
14 days
Secondary Outcomes (4)
Hba1C Data of Pre and Post Stem Cell Infusion
12 weeks
Insulin Level
12 weeks
Amylase Level
12 weeks
Serum Creatinine
12 weeks
Study Arms (1)
Autologous CD34+ stem cells
EXPERIMENTALUp to 5 x 10 log 8 of autologous stem cells on a single occasion
Interventions
Up to 5 x 10 log 8 of autologous stem cells on a single occasion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Imperial College NHS Healthcare Trust, Hammersmith Hospital
London, W12 0HS, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Professor Charles Pusey
- Organization
- Imperial College London
Study Officials
- PRINCIPAL INVESTIGATOR
Charles Pusey, MD
Imperial College London
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2008
First Posted
November 11, 2008
Study Start
November 1, 2008
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
November 18, 2019
Results First Posted
November 18, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share