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

Renal Failure Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01453816
• Other study ID #: ADI-ME-RF-001
• Status: Withdrawn
• Phase: N/A
• First received: October 3, 2011
• Last updated: July 19, 2017
• Start date: May 2011
• Est. completion date: June 2015

Study information

• Verified date: July 2017
• Source: Ageless Regenerative Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Renal Failure
• Renal Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Mexico	Hospital Angeles	Tijuana	Baja California

Sponsors (2)

Lead Sponsor	Collaborator
Ageless Regenerative Institute	Instituto de Medicina Regenerativa, S.A. de C.V.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significant clinical improvement in serum creatinine and urine output (improvement in measured Glomerular Filtration Rate(GFR) by 50%)	Compared to baseline	3 months
Primary	number of participants with adverse events		1 week
Primary	Significant clinical improvement in serum creatinine and urine output (improvement in measured Glomerular Filtration Rate(GFR) by 50%) at 6 months		6 months
Primary	number of participants with adverse events		2 weeks
Primary	number of participants with adverse events		4 weeks
Secondary	Improvement in renal biopsy measured by the reduction of scarring etc as compared to baseline		3 months
Secondary	Improvement in renal biopsy measured by the reduction of scarring etc as compared to baseline		6 months