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)
Overview
- Phase
- Phase 1
- Intervention
- Adipose Derived Stem Cell (ADSC) Therapy
- Conditions
- Chronic Obstructive Pulmonary Disease
- Sponsor
- Kimera Society Inc
- Enrollment
- 26
- Locations
- 5
- Primary Endpoint
- FEV1 Decline
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
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
Arms & Interventions
Adipose-Derived Stem Cell (ADSC) Therapy
This arm, as the sole arm, will consist of the ADSC treatment procedure. Intervention will consist of Adipose Derived Stem Cell (ADSC) Therapy
Intervention: Adipose Derived Stem Cell (ADSC) Therapy
Outcomes
Primary Outcomes
FEV1 Decline
Time Frame: 12 months
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
Time Frame: 12 months
Secondary Outcomes
- Secondary Efficacy Objective(12 Months)