Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adipose-Derived Stem Cell (ADSC) Therapy | Experimental | This arm, as the sole arm, will consist of the ADSC treatment procedure. Intervention will consist of Adipose Derived Stem Cell (ADSC) Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adipose Derived Stem Cell (ADSC) Therapy | Drug | Patients undergo a liposuction where 100 cc of fat are extracted. The ADSCs are then isolated and injected intravenously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 Decline | The primary efficacy outcome will be a FEV1 decline of approximately or less than 30 ml at 12 month follow-up. | 12 months |
| Number of Adverse Events | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Efficacy Objective | The secondary efficacy objective will be a decrease in six minute walking distance (6MWD) of less than 5% over one year. | 12 Months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Melvin Propis M.D. | Davie | Florida | 33330 | United States | ||
| Chicago |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Chicago |
| Illinois |
| 60061 |
| United States |
| Las Vegas | Las Vegas | Nevada | 89030 | United States |
| New York | New York | New York | 10001 | United States |
| Dallas | Dallas | Texas | 75251 | United States |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |