Adult Stem Cells
Adult Stem Cells

Adult Stem Cell Clinical Trial for patients with Frailty Syndrome

CLINICAL TRIAL

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

PURPOSE

The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe, and 2) Is treatment effective in improving the health of patients with human 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 (Clinical Trials Identifier: NCT01501461)

STUDY DESIGN & DATES

Phase I & II, Non-Randomized, Open Label
Study Start Date: May 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: Dec 2014 (Final data collection date for primary outcome measure)

CONTACTS

Kristin Comella
Phone: 813 390 9874
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

LOCATIONS

Mexico:

Instituto de Medicina Regenerativa
Tijuana, Baja California, Mexico, 22010

INVESTIGATORS

Principal Investigator: Clemente Zuniga, MD Instituto de Medicina Regenerativa

Principal Investigator: Jesus A Perez, MD Instituto de Medicina Regenerativa

ELIGIBILITY: 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

ELIGIBILITY: 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

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Adult Stem Cells
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