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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | This is the only arm and that is the treatment group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Adipose-derived Stem cells | Procedure | Intravenous administration of autologous activated stromal vascular fraction derived from 100-120 ml lipoaspirate following mini-liposuction of abdominal adipose tissue. |
| Measure | Description | Time Frame |
|---|---|---|
| Lowering of insulin-dependence and anti-hyperglycemic medication dosages | At 2, 4, 12, 24, 36, and 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Lowering of glycosylated hemoglobin (HbA1C). | At 4, 12, 24, 36, and 48 weeks | |
| Increased circulating C-Peptide levels | At 4, 12, 24, 36, and 48 weeks. | |
| Increased general well-being of patients. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Letitia Lucero-Palma, MD | Contact | 63-916-478-7512 | lettielucero@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Emeritta A Barrenechea, MD | Veterens Memorial Medical Centre, Philippines | Principal Investigator |
| Florencio Q Lucero, MD | University of Philippines, College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beverly Hills Medical Group | Recruiting | Makati City | Manila | Philippines |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17495232 | Background | Gimble JM, Katz AJ, Bunnell BA. Adipose-derived stem cells for regenerative medicine. Circ Res. 2007 May 11;100(9):1249-60. doi: 10.1161/01.RES.0000265074.83288.09. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
| At 2, 4, 12, 24, 36, and 48 weeks. |
| No detrimental change seen in kidney function tests, liver function tests and other haematological parameters. | At 2, 4, 12, 24, 36, and 48 weeks. |
| Letitia Lucero-Palma, MD | Far Eastern University-NRMF Hospital, Quezon City, Philippines | Study Director |
| Bill Paspaliaris, PhD | Adistem Ltd, Hong Kong | Study Chair |
| Veterens Memorial Medical Centre | Recruiting | Quezon City | Manila | 1229 | Philippines |
|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |