Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered in Patients With Renal Failure
This study is currently recruiting participants.
Verified November 2011 by Ageless Regenerative Institute
Sponsor:
Ageless Regenerative Institute
Collaborator:
Instituto de Medicina Regenerativa, S.A. de C.V.
Information provided by (Responsible Party):
Ageless Regenerative Institute
ClinicalTrials.gov Identifier:
NCT01453816
First received: October 3, 2011
Last updated: November 1, 2011
Last verified: November 2011
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Purpose
The intent of this clinical study is to answer the questions:
- Is the proposed treatment safe
- Is treatment effective in improving the disease pathology of patients with Renal Failure and clinical outcomes
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Failure |
Procedure: Harvesting and Isolation of Stem cells |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Into the Renal Artery and Intravenously in Patients With Renal Failure |
Further study details as provided by Ageless Regenerative Institute:
Primary Outcome Measures:
- Significant clinical improvement in serum creatinine and urine output (improvement in measured Glomerular Filtration Rate(GFR) by 50%) [ Time Frame: 3 months ] [ Designated as safety issue: No ]Compared to baseline
- number of participants with adverse events [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
- Significant clinical improvement in serum creatinine and urine output (improvement in measured Glomerular Filtration Rate(GFR) by 50%) at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- number of participants with adverse events [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
- number of participants with adverse events [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Improvement in renal biopsy measured by the reduction of scarring etc as compared to baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Improvement in renal biopsy measured by the reduction of scarring etc as compared to baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Procedure: Harvesting and Isolation of Stem cells
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Males and Females between Age 18 and 80 years.
- Chronic Kidney Disease(CKD) patients of stage III, IV, or V
- Patient should be afebrile 24 hours prior to procedure.
- Up to date on all age and gender appropriate cancer screening per American Cancer Society.
Exclusion Criteria:
- Acute Renal Failure
- Severe co-morbidities like cardiac insufficiency, congestive cardiac failure, malignancy, infection, sepsis and bed sores.
- Hemoglobin level below 6g/dl or at the discretion of the physician depending on patient's overall condition.
- Chronic kidney disease due to autoimmune aetiology, connective tissue disease, amyloidosis and storage disorders.
- Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
- Life expectancy < 6 months due to concomitant illnesses.
- Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
- Active infectious disease. Patients known to have tested positive for Human immunodeficiency virus (HIV), Human T-lymphotropic virus(HTLV), Hepatitis B (HBV),Hepatitis C (HCV), Cytomegalovirus (CMV) and/or syphilis will be evaluated by an expert as to patient eligibility based on the patient's infectious status
- Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
- Patients on chronic immunosuppressive transplant therapy
- Systolic blood pressure (supine) ≤90 mmHg or greater than 200mmHg
- Resting heart rate > 100 bpm;
- Active clinical infection within one week of enrollment.
- Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
- History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
- Unwilling and/or not able to give written informed consent.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01453816
Contacts
| Contact: Janny Garcia, Biomedical Engineer | (855) 274 -2355 | jgarcia@agelessregen.com |
| Contact: Kristin Comella, Chemical Engineer | kcomella@agelessregen.com |
Locations
| Mexico | |
| Hospital Angeles | Recruiting |
| Tijuana, Baja California, Mexico, 22010 | |
| Contact: Jesus A Perez, MD jesus.perez.md@gmail.com | |
| Contact: Javier Lopez, MD jjlopezg@ulam.net | |
| Principal Investigator: Rigoberto Pallares, MD | |
Sponsors and Collaborators
Ageless Regenerative Institute
Instituto de Medicina Regenerativa, S.A. de C.V.
Investigators
| Principal Investigator: | Rigoberto Pallares, MD | Instituto de Medicina Regenerativa |
More Information
No publications provided
| Responsible Party: | Ageless Regenerative Institute |
| ClinicalTrials.gov Identifier: | NCT01453816 History of Changes |
| Other Study ID Numbers: | ADI-ME-RF-001 |
| Study First Received: | October 3, 2011 |
| Last Updated: | November 1, 2011 |
| Health Authority: | Mexico: Federal Commission for Sanitary Risks Protection |
Keywords provided by Ageless Regenerative Institute:
|
Renal insufficiency kidney failure |
Additional relevant MeSH terms:
|
Renal Insufficiency Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013