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

NCT01501461 | Withdrawn

• 1 other identifier: ADI-ME-FS-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The intent of this clinical study is to answer the questions:

1. 1.Is the proposed treatment safe
2. 2.Is treatment effective in improving the health of patients with human frailty syndrome.

Conditions

Frailty Syndrome

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• Improved exercise capacity compared to baseline

  3 months

• Improved exercise capacity compared to baseline

  6 months

Interventions

Harvesting and implantation of stem cells PROCEDURE

The adipose tissue specimen will be collected from the patient's abdomen or applicable area using tumescent syringe liposuction. The adipose tissue is transferred to the laboratory for separation of the adipose tissue-derived stem cells, which are then transferred for injection intravenously.

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ageless Regenerative Institute: lead
• Instituto de Medicina Regenerativa: collaborator

Study Sites (1)

Instituto de Medicina Regenerativa

Tijuana, Estado de Baja California, 22010, Mexico

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clemente Zuniga, MD

  Instituto de Medicina Regenerativa

  PRINCIPAL INVESTIGATOR

• Jesus A Perez, MD

  Instituto de Medicina Regenerativa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2011
• First Posted: December 29, 2011
• Study Start: May 1, 2011
• Primary Completion: May 30, 2017
• Study Completion: June 30, 2017
• Last Updated: April 19, 2018

Record last verified: 2017-11

Locations

ME (1)