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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 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: April 7, 2016
Last verified: April 2016

March 19, 2012
April 7, 2016
March 2014
November 2017   (final data collection date for primary outcome measure)
  • 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 ]
  • Functional Capacity improved compared to baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Functional Capacity improvement compared to baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Improved quality of life compared to baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Improved quality of life compared to baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01559051 on ClinicalTrials.gov Archive Site
Quality of Life improved compared to baseline [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]
St. George Respiratory Questionnaire
Not Provided
Not Provided
Not Provided
 
Safety and Efficacy of Adipose Derived Stem Cells for Chronic Obstructive Pulmonary Disease
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
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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
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
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
Intervention: Procedure: Lipoaspiration with Local anesthesia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2017
November 2017   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact: Marcela Salgado, MD 305-933-2988 clinicaltrials@agelessinstitute.com
Contact: Noelle Smith, Manager 305-9332988 nsmith@agelessinstitute.com
United States
Mexico
 
NCT01559051
AD-US-COPD-001
No
Undecided
Not Provided
Ageless Regenerative Institute
Ageless Regenerative Institute
Not Provided
Principal Investigator: Sharon McQuillan, MD Ageless Regenerative Institute
Ageless Regenerative Institute
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP