Back to resultsSafety and Efficacy of Adipose Derived Stem Cells for Chronic Obstructive Pulmonary Disease
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lipoaspiration with Local anesthesia
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Pulmonary, Lungs
Eligibility 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.
Sites / Locations
- Ageless Regenerative Institute LLC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intravenous Injection and Inhalation infusion of AD-SVF
Arm Description
AD-SVF harvested from Autologous Adipose Tissue will be deliver after processing via IV and Inhalation
Outcomes
Primary Outcome Measures
Functional Capacity improved compared to baseline
6 Minute Walk Test
Number of adverse events
Secondary Outcome Measures
Quality of Life improved compared to baseline
St. George Respiratory Questionnaire
Full Information
NCT ID
NCT01559051
First Posted
March 19, 2012
Last Updated
November 21, 2017
Sponsor
Ageless Regenerative Institute
1. Study Identification
Unique Protocol Identification Number
NCT01559051
Brief Title
Safety and Efficacy of Adipose Derived Stem Cells for Chronic Obstructive Pulmonary Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Withdrawn
Why Stopped
company dissolved
Study Start Date
March 2014 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ageless Regenerative Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, Pulmonary, Lungs
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intravenous Injection and Inhalation infusion of AD-SVF
Arm Type
Experimental
Arm Description
AD-SVF harvested from Autologous Adipose Tissue will be deliver after processing via IV and Inhalation
Intervention Type
Procedure
Intervention Name(s)
Lipoaspiration with Local anesthesia
Other Intervention Name(s)
Liposuction
Intervention Description
Patients undergo a liposuction under local Anethesia. The AD-SVF are then isolated and infused IV and by inhalation delivery.
Primary Outcome Measure Information:
Title
Functional Capacity improved compared to baseline
Description
6 Minute Walk Test
Time Frame
3 months, 6 months
Title
Number of adverse events
Time Frame
3 months, 6 months
Secondary Outcome Measure Information:
Title
Quality of Life improved compared to baseline
Description
St. George Respiratory Questionnaire
Time Frame
3 months, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon McQuillan, MD
Organizational Affiliation
Ageless Regenerative Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ageless Regenerative Institute LLC
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Safety and Efficacy of Adipose Derived Stem Cells for Chronic Obstructive Pulmonary Disease
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