Safety and Efficacy of Autologous Adipose-Derived Stem Cell Transplantation in Type 2 Diabetics
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 Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Adistem Ltd
Information provided by:
Adistem Ltd
ClinicalTrials.gov Identifier:
NCT00703612
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-derived stem cells is of benefit in the management of types 2 diabetics.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 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 2 Diabetes |
Resource links provided by NLM:
Further study details as provided by Adistem Ltd:
Primary Outcome Measures:
- Lowering of blood glucose be it fasting, random or post prandial [ Time Frame: At 2, 4, 12, 24, 36, and 48 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Decrease in anti-hyperglycemic medication dosages. [ Time Frame: At 2, 4, 12, 24, 36, and 48 weeks. ] [ Designated as safety issue: Yes ]
- Improvement in the general well-being of patients. [ Time Frame: At 2, 4, 12, 24, 36, and 48 weeks. ] [ Designated as safety issue: Yes ]
- Lowering of glycosylated hemoglobin (HbA1C). [ Time Frame: At 4, 12, 24, 36, and 48 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 34 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | January 2009 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment Group
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.
|
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 1/Phase 2 study is to determine whether the intavenous administration of activated adipose-derived stromal vascular fraction as a single procedure is safe to and can benefit the disease pathology of patients with Type 2 Diabetes Mellitus (insulin resistance). Patients will be observed over 12 months following the procedure, with a 2 week, 1 month and then tri monthly diagnostics and life style questionaires.
Eligibility| Ages Eligible for Study: | 40 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Confirmed diagnosis of Type II diabetes for at least 2 years
- Type 2 diabetics on oral hypoglycemic agents and/or insulin
- Fasting blood sugar of >200mg% on at least two occasions
- Willing to keep a weekly diary and undergo observation for 12 months
Exclusion Criteria:
- Presence of of previous and/or acute diabetic complications such as myocardial infarction, CVA or nephropathy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00703612
Locations
| Philippines | |
| Beverly Hills Medical Group | |
| Makati City, Manila, Philippines, 1223 | |
| Veterens Memorial Medical Centre | |
| Quezon City, Manila, Philippines, 1229 | |
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 |
More Information
Additional Information:
Publications:
| Responsible Party: | Bill Paspaliaris / Director, Adistem Ltd |
| ClinicalTrials.gov Identifier: | NCT00703612 History of Changes |
| Other Study ID Numbers: | Adis-002 |
| 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 Hyperglycemia |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013