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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Frailty Syndrome
• Intervention / Treatment: Procedure: Harvesting and implantation of stem cells

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Physical Performance Test (PPT) Results		3 months
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.	up to 6 months
Improvement in Physical Performance Test (PPT) Results		6 months
Improved body composition/bone density compared to baseline		3 months
Improved body composition/bone density compared to baseline		6 months
Quality of life is improved compared to baseline		3 months
Quality of life is improved compared to baseline		6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Improved exercise capacity compared to baseline	3 months
Improved exercise capacity compared to baseline	6 months

Collaborators and Investigators

• Sponsor: Ageless Regenerative Institute
• Collaborators: Instituto de Medicina Regenerativa
• Investigators: Principal Investigator: Jesus A Perez, MD, Instituto de Medicina Regenerativa

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (ACTUAL): May 30, 2017
• Study Completion (ACTUAL): June 30, 2017

Study Registration Dates

• First Submitted: October 3, 2011
• First Submitted That Met QC Criteria: December 27, 2011
• First Posted (ESTIMATE): December 29, 2011

Study Record Updates

• Last Update Posted (ACTUAL): April 19, 2018
• Last Update Submitted That Met QC Criteria: April 17, 2018
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome; Frailty
• Other Study ID Numbers: ADI-ME-FS-001