Safety and Efficacy of Autologous Adipose-Derived Stem Cell Transplantation in Patients With Type 1 Diabetes
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Adistem Ltd.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Adistem Ltd
Information provided by:
Adistem Ltd
ClinicalTrials.gov Identifier:
NCT00703599
First received: June 19, 2008
Last updated: June 28, 2008
Last verified: June 2008
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Purpose
The purpose of this study is to determine whether intravenous administration of autologous adipose stem cells is safe and beneficial in patients with type 1 diabetes.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 1 Diabetes Mellitus |
Procedure: Autologous Adipose-derived Stem cells |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I/II Study of Intravenous Administration of Activated Autologous Adipose-Derived Stromal Vascular Fraction in Patients With Type 1 Diabetes |
Resource links provided by NLM:
Further study details as provided by Adistem Ltd:
Primary Outcome Measures:
- Lowering of insulin-dependence and anti-hyperglycemic medication dosages [ Time Frame: At 2, 4, 12, 24, 36, and 48 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Lowering of glycosylated hemoglobin (HbA1C). [ Time Frame: At 4, 12, 24, 36, and 48 weeks ] [ Designated as safety issue: Yes ]
- Increased circulating C-Peptide levels [ Time Frame: At 4, 12, 24, 36, and 48 weeks. ] [ Designated as safety issue: No ]
- Increased general well-being of patients. [ Time Frame: At 2, 4, 12, 24, 36, and 48 weeks. ] [ Designated as safety issue: Yes ]
- No detrimental change seen in kidney function tests, liver function tests and other haematological parameters. [ Time Frame: At 2, 4, 12, 24, 36, and 48 weeks. ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
This is the only arm and that is the treatment group.
|
Procedure: Autologous Adipose-derived Stem cells
Intravenous administration of autologous activated stromal vascular fraction derived from 100-120 ml lipoaspirate following mini-liposuction of abdominal adipose tissue.
Other Name: Treatment Group
|
Detailed Description:
Diabetes Mellitus is of large epidemic proportions worldwide. It is proliferating at such a fast rate that new novel drugs and other therapeutic approaches are required. The purpose of this Phase I/II study is to determine whether the intravenous administration of activated adipose-derived stromal vascular fraction as a single procedure is safe and efficacious in patients with Type 1 Diabetes Mellitus. Patients will be observed over 12 months following the procedure, with 2 weeks, 1 month and tri-monthly diagnostics and life style questionaires.
Eligibility| Ages Eligible for Study: | 16 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Confirmed diagnosis of Type I diabetes for at least 2 years
- Insulin-dependent
Exclusion Criteria:
- Presence of acute diabetic complications in the acute stage as recent myocardial infarction, recent CVA or acute renal failure.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00703599
Contacts
| Contact: Letitia Lucero-Palma, MD | 63-916-478-7512 | lettielucero@yahoo.com |
Locations
| Philippines | |
| Beverly Hills Medical Group | Recruiting |
| Makati City, Manila, Philippines | |
| Contact: Florencio Q Lucero, MD 63-917-896-6411 dr-flucero@pldtdsl.net | |
| Principal Investigator: Florencio Q Lucero, MD | |
| Veterens Memorial Medical Centre | Recruiting |
| Quezon City, Manila, Philippines, 1229 | |
| Contact: Emerita A Barrenechea, MD 63-917-811-1008 emieab@yahoo.com | |
| Principal Investigator: Emerita A Barrenechea, MD | |
Sponsors and Collaborators
Adistem Ltd
Investigators
| Principal Investigator: | Emeritta A Barrenechea, MD | Veterens Memorial Medical Centre, Philippines |
| Principal Investigator: | Florencio Q Lucero, MD | University of Philippines, College of Medicine |
| Study Director: | Letitia Lucero-Palma, MD | Far Eastern University-NRMF Hospital, Quezon City, Philippines |
| Study Chair: | Bill Paspaliaris, PhD | Adistem Ltd, Hong Kong |
More Information
Additional Information:
Publications:
| Responsible Party: | Bill Paspaliaris / Director, Adistem Ltd |
| ClinicalTrials.gov Identifier: | NCT00703599 History of Changes |
| Other Study ID Numbers: | Ad-003 |
| Study First Received: | June 19, 2008 |
| Last Updated: | June 28, 2008 |
| Health Authority: | Philippines: Department of Health |
Keywords provided by Adistem Ltd:
|
Diabetes Mellitus Adipose-derived stem cells Adipose stromal vascular fraction Autologous Insulin-dependence |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013