A Pilot study on the use of Allogeneic Mesenchymal stem cells with Chronic Obstructive Pulmonary Disease (COPD)

Stempeutics Research Pvt Ltd0 个研究点目标入组 30 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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

•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 α1-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 ≥ 1.5 mg%, Serum total bilirubin ≥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.

发起方