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| Name | Class |
|---|---|
| Instituto de Medicina Regenerativa | INDUSTRY |
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The intent of this clinical study is to answer the questions:
This will be an open-label, non-randomized multi-center patient sponsored study of Autologous Adipose-Derived Stem Cells (ASC) implantation after liposuction using an IV delivery system. 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. The cells will be delivered intravenously.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Harvesting and implantation of stem cells | Procedure | The adipose tissue specimen will be collected from the patient's abdomen or applicable area using tumescent syringe liposuction. The adipose tissue is transferred to the laboratory for separation of the adipose tissue-derived stem cells, which are then transferred for injection intravenously. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Physical Performance Test (PPT) Results | 3 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 6 months |
| Improvement in Physical Performance Test (PPT) Results | 6 months | |
| Improved body composition/bone density compared to baseline | 3 months | |
| Improved body composition/bone density compared to baseline | 6 months | |
| Quality of life is improved compared to baseline | 3 months | |
| Quality of life is improved compared to baseline | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improved exercise capacity compared to baseline | 3 months | |
| Improved exercise capacity compared to baseline | 6 months |
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Inclusion Criteria:
BMD< T-1 (Based on QCT results) Body Mass: males <8% or >17% fat, females<10% or>24% fat (Lean Body Mass=Total Body Mass- %Body Fat)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clemente Zuniga, MD | Instituto de Medicina Regenerativa | Principal Investigator |
| Jesus A Perez, MD | Instituto de Medicina Regenerativa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Medicina Regenerativa | Tijuana | Estado de Baja California | 22010 | Mexico |
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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