Safety and Efficacy of Adipose Derived Stem Cells for Chronic Obstructive Pulmonary Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Ageless Regenerative Institute
Sponsor:
Information provided by (Responsible Party):
Ageless Regenerative Institute
ClinicalTrials.gov Identifier:
NCT01559051
First received: March 19, 2012
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the health of patients with human Chronic Obstructive Pulmonary Disease.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Procedure: Adipose-Derived Stem Cell (ADSC) Therapy
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 Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by Ageless Regenerative Institute:

Primary Outcome Measures:
  • Functional Capacity improved compared to baseline [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]
    6 Minute Walk Test

  • Number of adverse events [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of Life improved compared to baseline [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]
    St. George Respiratory Questionnaire


Estimated Enrollment: 200
Study Start Date: March 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Adipose-Derived Stem Cell (ADSC) Therapy
    Patients undergo a liposuction where 120 cc of fat are extracted. The ADSCs are then isolated and injected intravenously.
Detailed Description:

This will be an open-label, non-randomized multi-center patient sponsored study of Autologous Stem Cell (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.

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 IV delivery. The number of cells injected will vary depending on the amount of tissue processed and the number of cells obtained from the process.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A prior diagnosis of moderate or severe COPD
  • GOLD III and IV
  • Age between 25 and 80 years
  • Up to date on all age and gender appropriate cancer screening per American Cancer Society

Exclusion Criteria:

  • Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
  • 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
  • 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.
  • Severe asthma that would contraindicate surgery
  • 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01559051

Contacts
Contact: Melissa Mayans 305-933-2988 clinicaltrials@agelessinstitute.com

Locations
United States, Florida
Ageless Institute Recruiting
Miami, Florida, United States, 33180
Contact: Melissa Mayans    305-933-2988    clinicaltrials@agelessinstitute.com   
Principal Investigator: Sharon McQuillan, MD         
Sponsors and Collaborators
Ageless Regenerative Institute
Investigators
Principal Investigator: Sharon McQuillan, MD Ageless Regenerative Institute
  More Information

No publications provided

Responsible Party: Ageless Regenerative Institute
ClinicalTrials.gov Identifier: NCT01559051     History of Changes
Other Study ID Numbers: IMR-EPOC-001
Study First Received: March 19, 2012
Last Updated: July 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ageless Regenerative Institute:
COPD
Pulmonary
Lungs

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 16, 2014