Health Condition 1: null- Chronic Obstructive Pulomonary Disease (COPD)
Conditions
Interventions
Intervention1: Ex vivo cultured adult allogenic MSCs: Single dose of Allogenic MSCs (either 2million or 5million cells per kg body weight) given intra venous.
Control Intervention1: Saline: 100 ml int
Sponsors
Stempeutics Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1)Patient must be diagnosed, suffering from chronic obstructive pulmonary disease (COPD) as per GOLD (Global Initiative for Chronic Obstructive Lung Disease) guidelines and radiological evidence suggestive of predominant emphysema. 2) Patient must have a post-bronchodilator FEV1 % predicted value ≥ 30% and < 80%. 3) Patient must be above 40 years of age, of either sex, and of any race 4) Patient must be a ex-smoker ( quit smoking for ≥ 6 months ), with a cigarette smoking history of ≥10 pack-years. 5) Patient should be fully conscious, alert, oriented to the time and place. 6) Patient should have the ability to understand the requirements of the therapy, provide written informed consent, abide by the treatment requirements, and agree to return for required follow-up
Exclusion criteria
Exclusion criteria: 1)Patient has been diagnosed with asthma or other clinically relevant lung disease other than COPD (e.g. restrictive lung diseases, Sarcoidosis, active Tuberculosis, Idiopathic pulmonary fibrosis, Bronchiectasis, or lung cancer). 2) Patient has been diagnosed with &#945;1-Antitrypsin deficiency . 3) Patient has clinical / hematological / surgical evidence of active infection at the time of screening. 4) Patient has had exacerbation of COPD which required hospitalization / oral or parenteral steroids within 4 weeks of screening. 5) Patient has documented (2 D ECHO) history of clinically overt cor-pulmonale, uncontrolled heart failure, pulmonary hypertension due to left heart condition, atrial fibrillation or significant congenital heart defect/disease. 6) Patient has initiated pulmonary rehabilitation within 3 months of screening. 7) Patient has evidence of active malignancy, or prior history of active malignancy that has not been in remission for at least 5 years. 8) Patient suffering from end stage of a disease. 9) Hb% < 10 gm%, Serum Creatinine &#8805; 1.5 mg%, Serum total bilirubin &#8805;2mg%, Hb AIC > 7%, leucocytosis (>11,000/cmm). 10) Women who are lactating or positive to pregnancy test. 11)Patients tested positive for antibodies to HIV, HCV, CMV, and HBsAg & VDRL. 12)Patient enrolled in any other study within 3 months of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability, assessed by adverse events. The type of AE(s), number of AE(s) and proportion of patients with AE(s) Timepoint: Baseline, 7th day, 1st month, 3rd month, 6th month, 9th month, 12th month. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in: 1) Improvement in Pulmonary function tests from baseline 2) Improvement in exercise capability from baseline (Six minute walk test) 3) Improvement in quality of life Index (St. Georges respiratory questionnaire) 4) Reduction in number of exacerbations/hospitalizations due to COPD 5) Radiological improvement in High resolution computerized tomography of chest ( HRCT) Baseline, 1st month, 3rd month, 6th month, 9th month, 12th month Timepoint: Baseline, 1st month, 3rd month, 6th month, 9th month, 12th month | — |
Countries
India
Contacts
Public ContactJiji Abhraham
Stempeutics Research Pvt. Ltd.
Outcome results
None listed