Study to Assess the Safety and Effects of Autologous Adipose-Derived Stem Cells in Patients With Frailty Syndrome

Not Applicable

Withdrawn

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 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.

Recruitment & Eligibility

Inclusion Criteria

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.

Primary Outcome Measures

Name	Time	Method
Improvement in Physical Performance Test (PPT) Results	6 months
Number of Adverse Events Reported	up to 6 months	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.
Improved body composition/bone density compared to baseline	6 months
Quality of life is improved compared to baseline	6 months

Secondary Outcome Measures

Name	Time	Method
Improved exercise capacity compared to baseline	6 months

Locations (1): Instituto de Medicina Regenerativa
🇲🇽
Tijuana, Baja California, Mexico