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No participants and no longer working with off shore center
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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:
Adipose-Derived Stromal Cells (ASCs) are a novel therapy for patients suffering from Renal failure. By injecting ASCs, these regions may become populated with the ASCs, thereby potentially restoring kidney function. ASCs are a patient-derived ("autologous") cell transplantation technology that is delivered to the patient. The therapy is composed of cells derived from a patients' own adipose tissue that are isolated within approximately 1 hour and immediately delivered back to the patient.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Harvesting and Isolation of Stem cells | Procedure | Adipose-Derived Stem Cells (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 via catheter into the renal artery and intravenously. |
| Measure | Description | Time Frame |
|---|---|---|
| Significant clinical improvement in serum creatinine and urine output (improvement in measured Glomerular Filtration Rate(GFR) by 50%) | Compared to baseline | 3 months |
| number of participants with adverse events | 1 week | |
| Significant clinical improvement in serum creatinine and urine output (improvement in measured Glomerular Filtration Rate(GFR) by 50%) at 6 months | 6 months | |
| number of participants with adverse events | 2 weeks | |
| number of participants with adverse events | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in renal biopsy measured by the reduction of scarring etc as compared to baseline | 3 months | |
| Improvement in renal biopsy measured by the reduction of scarring etc as compared to baseline | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rigoberto Pallares, MD | Instituto de Medicina Regenerativa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Angeles | Tijuana | Estado de Baja California | 22010 | Mexico |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |