Phase 1
N=7
Autologous Adult Stem Cells to Patients With Type 1 Diabetes and a Successful Renal Transplant
Type 1 Diabetes · Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00788827 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Number of Participants Who Experienced Adverse Events — 1; 7 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Autologous CD34+ stem cells (Biological)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced Adverse Events |
1; 7 | — |
| SECONDARY Hba1C Data of Pre and Post Stem Cell Infusion |
7.2; 7.24 | <0.05 sig |
| SECONDARY Insulin Level |
59.4; 54.06 | — |
| SECONDARY Amylase Level |
48.49; 75.52 | — |
| SECONDARY Serum Creatinine |
128.22; 118.64 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00788827). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.