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This will be an open-label, non-randomized, multi-center, patient sponsored study of Adipose-Derived Stromal vascular fraction cells implantation via intravenous infusion.
The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with diagnosed Type II Diabetes Mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Injection of AD-SVF | Experimental | Intravenous administration of AD-SVF. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Harvesting and Implantation of Adipose-Derived Stromal Vascular Fraction (AD-SVF) | Procedure | ASCs will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of insulin requirement by > 50% | 3 months and 6 months | |
| Number of adverse events reported | The safety of adipose-derived stem cell injection will be evaluated by assessment of the frequency and nature of adverse events occurring during the study injection and up to the 6-month period following treatment. | up to the 6-month period following treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of Hemoglobin A1c(HbA1c) levels as compared to baseline | Blood sample | 3 months and 6 months |
| reduction in requirement of insulin dosage compared to baseline | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon McQuillan, MD | Ageless Regenerative Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ageless Regenerative Institute LLC | Aventura | Florida | 33180 | United States |
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|
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| 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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| ID | Term |
|---|---|
| D015187 | Lipectomy |
| ID | Term |
|---|---|
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
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