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

NCT01453816 | Withdrawn

• 1 other identifier: ADI-ME-RF-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Conditions

Renal Failure

Keywords

Renal insufficiency; kidney failure

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (2)

• 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

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ageless Regenerative Institute: lead
• Instituto de Medicina Regenerativa: collaborator

Study Sites (1)

Hospital Angeles

Tijuana, Estado de Baja California, 22010, Mexico

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Rigoberto Pallares, MD

  Instituto de Medicina Regenerativa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2011
• First Posted: October 18, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: June 1, 2015
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

ME (1)