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Poor enrollment
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The purpose of this study is: 1.- to assess the safety and tolerability of autologous adipose derived stem cells (aADSC) administered intravenously in patients with chronic obstructive pulmonary disease, and 2.- to assess if this therapy results in less decrease of lung function parameters (FEV1, FEV1/FVC and 6 min walking distance) compared with a control baseline of 6 weeks.
Patients will be followed up for 12 months after the therapy.
STUDY DESIGN This is a Phase I open- label single-dose study in subjects with significant COPD. This is an expanded safety cohort. The investigators will enroll a minimum of 30 subjects. 6 week data of FEV1, FEV1/FVC, DLCO and 6 min walking distance values will be collected in all patients who are enrolled in the study (Baseline and 6 weeks after). Prior to the stem cell treatment, the patient will be assessed for 6 weeks by pulmonary function tests and 6 min walk tests. Then, patients will receive the infusion of stromal vascular fraction cells containing the aADSC (single intravenous dose). The standard therapy of COPD patients will not be interrupted during the duration of the study. Safety will be monitored on an ongoing basis, and an interim safety review will be conducted by the Investigator(s) and Sponsor after the first 20 patients have been enrolled and treated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADSCs administration | Experimental | Patients with Chronic Obstructive Pulmonary Disease will be treated with a single dose of autologous adipose derived stem cells. Stem cells will be isolated using standard Lipoaspiration procedure under sterile conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADSCs administration | Biological | 100- 240 cc of lipoaspirate will be extracted from the patient. The stromal vascular fraction (SVF) will be isolated with minimal manipulation. The cell pellet will be reconstituted in saline solution and administered intravenously to the patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of adipose derived stem cells (ADSC) in Patient with COPD | Safety/tolerability of Adipose Derived Stem Cell (ADSC) in patients with Chronic Obstructive Pulmonary Disease (COPD) during the twelve-month study period as determined by the incidence and severity of of adverse events. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of ADSC in improving Shortness of Breath (SOB) | The change (decrease) in patient Shortness Of Breath (SOB) as compared to baseline, measured in breath per minute, after administration of adipose derived stem cells (ADSC) | 2, 6 and 12 months |
| Efficacy of ADSC In Pulmonary Function Test (PFTs) |
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Inclusion Criteria:
10. Written informed consent. 11. Non-smoker or Past smoker, with 20 pack-years or more history
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Holder, MD | Arkansas Heart Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Heart Hospital | Little Rock | Arkansas | 72211 | United States | ||
| Arkansas Site Management Services LLC |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Phase I open label study to assess safety and tolerability
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The change (improvement) in Pulmonary Function Test (PFTs) after administration of adipose derived stem cells (ADSC) as compared to baseline. |
| 2, 6, 12 months |
| Efficacy of adipose derived stem cell in 6 MWT | Improvement in patient ability to walk as measure using a 6 minute walk test ( in meter) as compared to baseline | 2, 6, 12 months |
| Efficacy of adipose derived stem cells in patient's perceived exertion. | The change from baseline in patient perceived exertion as measure using the modified BORG scale or Rate of perceive exertion (RPE) which ranges from 1(no perceived exertion at all) to 10 (maximum perceived exertion) | 2, 6, 12 months |
| Efficacy in Quality of life using George's Respiratory Questionnaire | The change from baseline in patient quality of life as measure using the George's Respiratory Questionnaire | 2, 6, 12 months |
| Efficacy in Quality of life using the Chronic Respiratory questionnaires | The change from baseline in patient quality of life as measure using the Chronic Respiratory Questionnaire | 2, 6, 12 months |
| Little Rock |
| Arkansas |
| 72211 |
| United States |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |