Back to resultsStudy to Assess the Safety and Effects of Autologous Adipose-Derived Stem Cells in Patients With Frailty Syndrome
Primary Purpose
Frailty Syndrome
Status
Withdrawn
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Harvesting and implantation of stem cells
Sponsored by
About this trial
This is an interventional treatment trial for Frailty Syndrome
Eligibility Criteria
Inclusion Criteria:
- Males and Females Age >55.
- Frailty syndrome defined by:
BMD< T-1 (Based on QCT results) Body Mass: males <8% or >17% fat, females<10% or>24% fat (Lean Body Mass=Total Body Mass- %Body Fat)
- Ability to participate in the short physical performance battery
- Up to date on all age and gender appropriate cancer screening per American Cancer Society
Exclusion Criteria:
- 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 HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis. will have an expert consulted 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
- Active clinical infection being treated by antibiotics 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
- Instituto de Medicina Regenerativa
Outcomes
Primary Outcome Measures
Improvement in Physical Performance Test (PPT) Results
Number of Adverse Events Reported
The safety of adipose-derived stem cell injection will be evaluated by assessment of the frequency and nature of adverse events occurring during the study injection and up to the 6-month period following treatment.
Improvement in Physical Performance Test (PPT) Results
Improved body composition/bone density compared to baseline
Improved body composition/bone density compared to baseline
Quality of life is improved compared to baseline
Quality of life is improved compared to baseline
Secondary Outcome Measures
Improved exercise capacity compared to baseline
Improved exercise capacity compared to baseline
Full Information
NCT ID
NCT01501461
First Posted
October 3, 2011
Last Updated
April 17, 2018
Sponsor
Ageless Regenerative Institute
Collaborators
Instituto de Medicina Regenerativa
1. Study Identification
Unique Protocol Identification Number
NCT01501461
Brief Title
Study to Assess the Safety and Effects of Autologous Adipose-Derived Stem Cells in Patients With Frailty Syndrome
Official Title
An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Intra-venous Implantation of Autologous Adipose-Derived Stem Cells in Patients With Frailty Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Company dissolved
Study Start Date
May 1, 2011 (undefined)
Primary Completion Date
May 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)
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 health of patients with human frailty syndrome.
Detailed Description
This will be an open-label, non-randomized multi-center patient sponsored study of Autologous Adipose-Derived Stem Cells (ASC) implantation after liposuction using an IV delivery system. 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 intravenously.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty Syndrome
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 implantation of stem cells
Intervention Description
The adipose tissue specimen will be collected from the patient's abdomen or applicable area using tumescent syringe liposuction. The adipose tissue is transferred to the laboratory for separation of the adipose tissue-derived stem cells, which are then transferred for injection intravenously.
Primary Outcome Measure Information:
Title
Improvement in Physical Performance Test (PPT) Results
Time Frame
3 months
Title
Number of Adverse Events Reported
Description
The safety of adipose-derived stem cell injection will be evaluated by assessment of the frequency and nature of adverse events occurring during the study injection and up to the 6-month period following treatment.
Time Frame
up to 6 months
Title
Improvement in Physical Performance Test (PPT) Results
Time Frame
6 months
Title
Improved body composition/bone density compared to baseline
Time Frame
3 months
Title
Improved body composition/bone density compared to baseline
Time Frame
6 months
Title
Quality of life is improved compared to baseline
Time Frame
3 months
Title
Quality of life is improved compared to baseline
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Improved exercise capacity compared to baseline
Time Frame
3 months
Title
Improved exercise capacity compared to baseline
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and Females Age >55.
Frailty syndrome defined by:
BMD< T-1 (Based on QCT results) Body Mass: males <8% or >17% fat, females<10% or>24% fat (Lean Body Mass=Total Body Mass- %Body Fat)
Ability to participate in the short physical performance battery
Up to date on all age and gender appropriate cancer screening per American Cancer Society
Exclusion Criteria:
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 HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis. will have an expert consulted 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
Active clinical infection being treated by antibiotics 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
Clemente Zuniga, MD
Organizational Affiliation
Instituto de Medicina Regenerativa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jesus A Perez, MD
Organizational Affiliation
Instituto de Medicina Regenerativa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Medicina Regenerativa
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 Stem Cells in Patients With Frailty Syndrome
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