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Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered in Patients With Renal Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01453816
Recruitment Status : Withdrawn (No participants and no longer working with off shore center)
First Posted : October 18, 2011
Last Update Posted : July 21, 2017
Sponsor:
Collaborator:
Instituto de Medicina Regenerativa, S.A. de C.V.
Information provided by (Responsible Party):
Ageless Regenerative Institute

Study Description
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Brief Summary:

The intent of this clinical study is to answer the questions:

  1. Is the proposed treatment safe
  2. Is treatment effective in improving the disease pathology of patients with Renal Failure and clinical outcomes

Condition or disease Intervention/treatment Phase
Renal Failure Procedure: Harvesting and Isolation of Stem cells Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2011
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : June 2015
Arms and Interventions
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  1. Significant clinical improvement in serum creatinine and urine output (improvement in measured Glomerular Filtration Rate(GFR) by 50%) [ Time Frame: 3 months ]
    Compared to baseline

  2. number of participants with adverse events [ Time Frame: 1 week ]
  3. 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 ]
  4. number of participants with adverse events [ Time Frame: 2 weeks ]
  5. number of participants with adverse events [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Improvement in renal biopsy measured by the reduction of scarring etc as compared to baseline [ Time Frame: 3 months ]
  2. Improvement in renal biopsy measured by the reduction of scarring etc as compared to baseline [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01453816


Locations
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Mexico
Hospital Angeles
Tijuana, Baja California, Mexico, 22010
Sponsors and Collaborators
Ageless Regenerative Institute
Instituto de Medicina Regenerativa, S.A. de C.V.
Investigators
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Principal Investigator: Rigoberto Pallares, MD Instituto de Medicina Regenerativa
More Information
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Responsible Party: Ageless Regenerative Institute
ClinicalTrials.gov Identifier: NCT01453816    
Other Study ID Numbers: ADI-ME-RF-001
First Posted: October 18, 2011    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Keywords provided by Ageless Regenerative Institute:
Renal insufficiency
kidney failure
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases