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

This study is currently recruiting participants.
Verified December 2011 by Ageless Regenerative Institute
Sponsor:
Collaborator:
Instituto de Medicina Regenerativa, S.A. de C.V.
Information provided by (Responsible Party):
Ageless Regenerative Institute
ClinicalTrials.gov Identifier:
NCT01501461
First received: October 3, 2011
Last updated: December 27, 2011
Last verified: December 2011
History of Changes
  Purpose

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.

Condition Intervention Phase
Frailty Syndrome
 Procedure: Harvesting and implantation of stem cells
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Bone Density
U.S. FDA Resources

Further study details as provided by Ageless Regenerative Institute:

Primary Outcome Measures:
  • Improvement in Physical Performance Test (PPT) Results [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Number of Adverse Events Reported [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
    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.

  • Improvement in Physical Performance Test (PPT) Results [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Improved body composition/bone density compared to baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Improved body composition/bone density compared to baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Quality of life is improved compared to baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Quality of life is improved compared to baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improved exercise capacity compared to baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Improved exercise capacity compared to baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: May 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Harvesting and implantation of stem cells
    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.
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

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01501461

Contacts
Contact: Janny Garcia, Biomedical Engineer (855) 274 -2355 jgarcia@agelessregen.com
Contact: Kristin Comella, Chemical Engineer (855) 274 -2355 kcomella@agelessregen.com

Locations
Mexico
Instituto de Medicina Regenerativa Recruiting
Tijuana, Baja California, Mexico, 22010
Contact: Jesus Perez, md            
Sponsors and Collaborators
Ageless Regenerative Institute
Instituto de Medicina Regenerativa, S.A. de C.V.
Investigators
Principal Investigator: Clemente Zuniga, MD Instituto de Medicina Regenerativa
Principal Investigator: Jesus A Perez, MD Instituto de Medicina Regenerativa
  More Information

No publications provided

Responsible Party: Ageless Regenerative Institute
ClinicalTrials.gov Identifier: NCT01501461     History of Changes
Other Study ID Numbers: ADI-ME-FS-001
Study First Received: October 3, 2011
Last Updated: December 27, 2011
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection

ClinicalTrials.gov processed this record on June 18, 2013