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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Renal Failure
• Intervention / Treatment: Procedure: Harvesting and Isolation of Stem cells

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Baja California
    • Tijuana, Baja California, Mexico, 22010
      • Hospital Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of participants with adverse events		4 weeks
number of participants with adverse events		1 week
number of participants with adverse events		2 weeks
Significant clinical improvement in serum creatinine and urine output (improvement in measured Glomerular Filtration Rate(GFR) by 50%)	Compared to baseline	3 months
Significant clinical improvement in serum creatinine and urine output (improvement in measured Glomerular Filtration Rate(GFR) by 50%) at 6 months		6 months

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Ageless Regenerative Institute
• Collaborators: Instituto de Medicina Regenerativa
• Investigators: Principal Investigator: Rigoberto Pallares, MD, Instituto de Medicina Regenerativa

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: October 3, 2011
• First Submitted That Met QC Criteria: October 17, 2011
• First Posted (Estimate): October 18, 2011

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 19, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: kidney failure; Renal insufficiency
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: ADI-ME-RF-001