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

Frailty Syndrome Clinical Trial

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Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01501461
• Other study ID #: ADI-ME-FS-001
• Status: Withdrawn
• Phase: N/A
• First received: October 3, 2011
• Last updated: April 17, 2018
• Start date: May 1, 2011
• Est. completion date: June 30, 2017

Study information

• Verified date: November 2017
• Source: Ageless Regenerative Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2017
• Est. primary completion date: May 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 90 Years

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

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.

Related Conditions & MeSH terms

• Frailty Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Mexico	Instituto de Medicina Regenerativa	Tijuana	Baja California

Sponsors (2)

Lead Sponsor	Collaborator
Ageless Regenerative Institute	Instituto de Medicina Regenerativa, S.A. de C.V.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Physical Performance Test (PPT) Results		3 months
Primary	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
Primary	Improvement in Physical Performance Test (PPT) Results		6 months
Primary	Improved body composition/bone density compared to baseline		3 months
Primary	Improved body composition/bone density compared to baseline		6 months
Primary	Quality of life is improved compared to baseline		3 months
Primary	Quality of life is improved compared to baseline		6 months
Secondary	Improved exercise capacity compared to baseline		3 months
Secondary	Improved exercise capacity compared to baseline		6 months