Safety and Efficacy of Autologous Adipose-Derived Stem Cell Transplantation in Patients With Type 1 Diabetes
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00703599 |
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Recruitment Status
: Unknown
Verified June 2008 by Adistem Ltd.
Recruitment status was: Recruiting
First Posted
: June 23, 2008
Last Update Posted
: July 1, 2008
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Sponsor:
Adistem Ltd
Information provided by:
Adistem Ltd
- Study Details
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Type 1 Diabetes Mellitus | Procedure: Autologous Adipose-derived Stem cells | Phase 1 Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 30 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (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 |
| Study Start Date : | November 2007 |
| Estimated Primary Completion Date : | November 2009 |
| Estimated Study Completion Date : | December 2009 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Type 1 diabetes
MedlinePlus related topics:
Diabetes Type 1
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
This is the only arm and that is the treatment group.
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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
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Primary Outcome Measures
:
- Lowering of insulin-dependence and anti-hyperglycemic medication dosages [ Time Frame: At 2, 4, 12, 24, 36, and 48 weeks ]
Secondary Outcome Measures
:
- Lowering of glycosylated hemoglobin (HbA1C). [ Time Frame: At 4, 12, 24, 36, and 48 weeks ]
- Increased circulating C-Peptide levels [ Time Frame: At 4, 12, 24, 36, and 48 weeks. ]
- Increased general well-being of patients. [ Time Frame: At 2, 4, 12, 24, 36, and 48 weeks. ]
- 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. ]
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| Ages Eligible for Study: | 16 Years to 60 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Publications:
| Responsible Party: | Bill Paspaliaris / Director, Adistem Ltd |
| ClinicalTrials.gov Identifier: | NCT00703599 History of Changes |
| Other Study ID Numbers: |
Ad-003 |
| First Posted: | June 23, 2008 Key Record Dates |
| Last Update Posted: | July 1, 2008 |
| Last Verified: | June 2008 |
Keywords provided by Adistem Ltd:
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Diabetes Mellitus Adipose-derived stem cells Adipose stromal vascular fraction Autologous Insulin-dependence |
Additional relevant MeSH terms:
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Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |