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

This study has been terminated.
(Company dissolved)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01501461
First Posted: December 29, 2011
Last Update Posted: November 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Instituto de Medicina Regenerativa, S.A. de C.V.
Information provided by (Responsible Party):
Ageless Regenerative Institute
  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
Frailty Syndrome Procedure: Harvesting and implantation of stem cells

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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

Further study details as provided by Ageless Regenerative Institute:

Primary Outcome Measures:
  • Improvement in Physical Performance Test (PPT) Results [ Time Frame: 3 months ]
  • Number of Adverse Events Reported [ Time Frame: up to 6 months ]
    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 ]
  • Improved body composition/bone density compared to baseline [ Time Frame: 3 months ]
  • Improved body composition/bone density compared to baseline [ Time Frame: 6 months ]
  • Quality of life is improved compared to baseline [ Time Frame: 3 months ]
  • Quality of life is improved compared to baseline [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Improved exercise capacity compared to baseline [ Time Frame: 3 months ]
  • Improved exercise capacity compared to baseline [ Time Frame: 6 months ]

Estimated Enrollment: 10
Study Start Date: May 1, 2011
Study Completion Date: June 30, 2017
Primary Completion Date: May 30, 2017 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01501461


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

Responsible Party: Ageless Regenerative Institute
ClinicalTrials.gov Identifier: NCT01501461     History of Changes
Other Study ID Numbers: ADI-ME-FS-001
First Submitted: October 3, 2011
First Posted: December 29, 2011
Last Update Posted: November 24, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Syndrome
Disease
Pathologic Processes