Clinical trial NCT01501461: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Frailty Syndrome
Lead sponsor: Ageless Regenerative Institute
Sponsor class: INDUSTRY
Collaborators: name: Instituto de Medicina Regenerativa
First posted: 2011-12-29
Enrollment: 0
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Improvement in Physical Performance Test (PPT) Results
timeFrame: 3 months
measure: Number of Adverse Events Reported
timeFrame: up to 6 months
measure: Improvement in Physical Performance Test (PPT) Results
timeFrame: 6 months
measure: Improved body composition/bone density compared to baseline
timeFrame: 3 months
measure: Improved body composition/bone density compared to baseline
timeFrame: 6 months
measure: Quality of life is improved compared to baseline
timeFrame: 3 months
measure: Quality of life is improved compared to baseline
timeFrame: 6 months
Secondary outcomes:
measure: Improved exercise capacity compared to baseline
timeFrame: 3 months
measure: Improved exercise capacity compared to baseline
timeFrame: 6 months
Other outcomes:
Locations:
city: Tijuana
country: Mexico
facility: Instituto de Medicina Regenerativa
state: Baja California
Study officials:
affiliation: Instituto de Medicina Regenerativa
name: Clemente Zuniga, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto de Medicina Regenerativa
name: Jesus A Perez, MD
role: PRINCIPAL_INVESTIGATOR
References: