Status:
WITHDRAWN
Study to Assess the Safety and Effects of Autologous Adipose-Derived Stem Cells in Patients With Frailty Syndrome
Lead Sponsor:
Ageless Regenerative Institute
Collaborating Sponsors:
Instituto de Medicina Regenerativa
Conditions:
Frailty Syndrome
Eligibility:
All Genders
55-90 years
Phase:
NA
Brief 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 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01501461
Start Date
May 1 2011
End Date
June 30 2017
Last Update
April 19 2018
Active Locations (1)
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1
Instituto de Medicina Regenerativa
Tijuana, Estado de Baja California, Mexico, 22010