Type 2 Diabetes Clinical Trial
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
Verified date | October 2019 |
Source | Imperial College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 7 |
Est. completion date | May 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Imperial College NHS Healthcare Trust, Hammersmith Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Imperial College London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Hba1C Data of Pre and Post Stem Cell Infusion | Mean HbA1c laboratory measurements pre and post stem cell infusion | 12 weeks | |
Secondary | Insulin Level | Mean insulin requirement was calculated for each participant pre and post stem cell infusion | 12 weeks | |
Secondary | Amylase Level | Each participant had mean amylase data analysed to give a pre and post mean result | 12 weeks | |
Secondary | Serum Creatinine | Each participant had serum creatinine analysis pre and post stem cell infusion to give mean result | 12 weeks |
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