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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Ageless Regenerative Institute
Sponsor:
Information provided by (Responsible Party):
Ageless Regenerative Institute
ClinicalTrials.gov Identifier:
NCT01559051
First received: March 19, 2012
Last updated: September 19, 2016
Last verified: September 2016
  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: Lipoaspiration with Local anesthesia
Phase 1
Phase 2

Study Type: Interventional
Study Design: 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 and Inhalation Implantation of Autologous Adipose-Derived Stromal Vascular Fraction 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: 100
Study Start Date: March 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intravenous Injection and Inhalation infusion of AD-SVF
AD-SVF harvested from Autologous Adipose Tissue will be deliver after processing via IV and Inhalation
Procedure: Lipoaspiration with Local anesthesia
Patients undergo a liposuction under local Anethesia. The AD-SVF are then isolated and infused IV and by inhalation delivery.
Other Name: Liposuction

Detailed Description:

This will be an open-label, non-randomized multi-center patient sponsored study of Autologous SVF (AD-SVF) implantation after liposuction using an IV delivery system and Inhalation infusion. AD-SVF 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   (Adult, Senior)
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: Janette M Daher 9547447400 ext 2727 clinicaltrials@agelessinstitute.com
Contact: Sharon McQuillan, MD 305-9332988 clinicaltrials@agelessinstitute.com

Locations
United States, Florida
Ageless Regenerative Institute LLC Recruiting
Aventura, Florida, United States, 33180
Contact: Sharon McQuillan, MD    305-933-2988 ext 4455    clinicaltrials@agelessinstitute.com   
Contact: Sharon McQuillan, MD    305-9332988    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

Responsible Party: Ageless Regenerative Institute
ClinicalTrials.gov Identifier: NCT01559051     History of Changes
Other Study ID Numbers: AD-US-COPD-001 
Study First Received: March 19, 2012
Last Updated: September 19, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

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 September 27, 2016