Back to resultsStudy to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered in Patients With Renal Failure
Primary Purpose
Renal Failure
Status
Withdrawn
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Harvesting and Isolation of Stem cells
Sponsored by
About this trial
This is an interventional treatment trial for Renal Failure focused on measuring Renal insufficiency, kidney failure
Eligibility 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.
Sites / Locations
- Hospital Angeles
Outcomes
Primary Outcome Measures
Significant clinical improvement in serum creatinine and urine output (improvement in measured Glomerular Filtration Rate(GFR) by 50%)
Compared to baseline
number of participants with adverse events
Significant clinical improvement in serum creatinine and urine output (improvement in measured Glomerular Filtration Rate(GFR) by 50%) at 6 months
number of participants with adverse events
number of participants with adverse events
Secondary Outcome Measures
Improvement in renal biopsy measured by the reduction of scarring etc as compared to baseline
Improvement in renal biopsy measured by the reduction of scarring etc as compared to baseline
Full Information
NCT ID
NCT01453816
First Posted
October 3, 2011
Last Updated
July 19, 2017
Sponsor
Ageless Regenerative Institute
Collaborators
Instituto de Medicina Regenerativa
1. Study Identification
Unique Protocol Identification Number
NCT01453816
Brief Title
Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered in Patients With Renal Failure
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 Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Withdrawn
Why Stopped
No participants and no longer working with off shore center
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
June 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ageless Regenerative Institute
Collaborators
Instituto de Medicina Regenerativa
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure
Keywords
Renal insufficiency, kidney failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Harvesting and Isolation of Stem cells
Intervention Description
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.
Primary Outcome Measure Information:
Title
Significant clinical improvement in serum creatinine and urine output (improvement in measured Glomerular Filtration Rate(GFR) by 50%)
Description
Compared to baseline
Time Frame
3 months
Title
number of participants with adverse events
Time Frame
1 week
Title
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
Title
number of participants with adverse events
Time Frame
2 weeks
Title
number of participants with adverse events
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Improvement in renal biopsy measured by the reduction of scarring etc as compared to baseline
Time Frame
3 months
Title
Improvement in renal biopsy measured by the reduction of scarring etc as compared to baseline
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rigoberto Pallares, MD
Organizational Affiliation
Instituto de Medicina Regenerativa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Angeles
City
Tijuana
State/Province
Baja California
ZIP/Postal Code
22010
Country
Mexico
12. IPD Sharing Statement
Learn more about this trial
Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered in Patients With Renal Failure
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