Back to resultsSafety and Efficacy of Adipose Derived Stem Cells for Chronic Obstructive Pulmonary Disease
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Adipose Derived Stem Cell (ADSC) Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD
Eligibility Criteria
Inclusion Criteria:
- Age 18 to 85, inclusive
- A prior diagnosis of moderate to severe COPD
- GOLD IIa, III, IV
Exclusion Criteria:
- Pregnant or lactating
- 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.
- Any illness which, in the Investigators judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of study results
- Subjects on chronic immunosuppressive or chemotherapeutic 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.
- Subjects with Alpha-1 antitrypsin deficiency (an inherited disorder that can cause lung disease and liver disease).
- Unwilling and/or not able to give written consent
- Patient is positive for hepatitis (past history of Hepatitis A is allowed)
- Any medical condition, which in the opinion of the clinical investigator, would interfere with the treatment or outcome of the patient
- Cerebral aneurysm clips
Sites / Locations
- Melvin Propis M.D.
- Chicago
- Las Vegas
- New York
- Dallas
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Adipose-Derived Stem Cell (ADSC) Therapy
Arm Description
This arm, as the sole arm, will consist of the ADSC treatment procedure. Intervention will consist of Adipose Derived Stem Cell (ADSC) Therapy
Outcomes
Primary Outcome Measures
FEV1 Decline
The primary efficacy outcome will be a FEV1 decline of approximately or less than 30 ml at 12 month follow-up.
Number of Adverse Events
Secondary Outcome Measures
Secondary Efficacy Objective
The secondary efficacy objective will be a decrease in six minute walking distance (6MWD) of less than 5% over one year.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02216630
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 Intravenous Implantation of Liposuction Derived Autologous Adipose-derived Stem Cells in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kimera Society Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This will be an open-label, non-randomized multi-center study designed to assess the safety and efficacy of Adipose-derived Stem Cell (ASC) IV implantation. The therapy is composed of cells isolated from a patient's own adipose tissue. Liposuction will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells.
Detailed Description
In the context of the proposed study, adipose derived stem cells (ASC) constitute an autologous cell product that is delivered to the patient via intra-venous injection. In this study, we propose to investigate the immunosuppressive potential of the non-manipulated non-cultured stromal vascular fraction obtained via liposuction. Endpoints will be measured both by improvement of the forced evacuation volume in one second (FEV1) and distance covered in a 6 minute walk distance test (6MWD). The stromal vascular fraction comprises stromal cells isolated from total fat via enzymatic digestion ex-vivo. These cells are not cultured but are isolated from adipose tissue using a sterile tissue process in under two hours. The process includes rinsing in a saline solution to remove red blood cells, draining, and enzymatic digestion (collagenase) which isolates endothelial cells from adipose tissue. Post-processing, the pellet obtained via centrifugation is filtered and delivered to the patient who remains sedated within the same ambulatory center.
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
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
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adipose-Derived Stem Cell (ADSC) Therapy
Arm Type
Experimental
Arm Description
This arm, as the sole arm, will consist of the ADSC treatment procedure. Intervention will consist of Adipose Derived Stem Cell (ADSC) Therapy
Intervention Type
Drug
Intervention Name(s)
Adipose Derived Stem Cell (ADSC) Therapy
Intervention Description
Patients undergo a liposuction where 100 cc of fat are extracted. The ADSCs are then isolated and injected intravenously.
Primary Outcome Measure Information:
Title
FEV1 Decline
Description
The primary efficacy outcome will be a FEV1 decline of approximately or less than 30 ml at 12 month follow-up.
Time Frame
12 months
Title
Number of Adverse Events
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Secondary Efficacy Objective
Description
The secondary efficacy objective will be a decrease in six minute walking distance (6MWD) of less than 5% over one year.
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 to 85, inclusive
A prior diagnosis of moderate to severe COPD
GOLD IIa, III, IV
Exclusion Criteria:
Pregnant or lactating
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.
Any illness which, in the Investigators judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of study results
Subjects on chronic immunosuppressive or chemotherapeutic 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.
Subjects with Alpha-1 antitrypsin deficiency (an inherited disorder that can cause lung disease and liver disease).
Unwilling and/or not able to give written consent
Patient is positive for hepatitis (past history of Hepatitis A is allowed)
Any medical condition, which in the opinion of the clinical investigator, would interfere with the treatment or outcome of the patient
Cerebral aneurysm clips
Facility Information:
Facility Name
Melvin Propis M.D.
City
Davie
State/Province
Florida
ZIP/Postal Code
33330
Country
United States
Facility Name
Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60061
Country
United States
Facility Name
Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89030
Country
United States
Facility Name
New York
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States
Facility Name
Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Adipose Derived Stem Cells for Chronic Obstructive Pulmonary Disease
We'll reach out to this number within 24 hrs