CTRI/2011/08/001936Other2 期
A randomized, double blind, multicentric, placebo controlled, phase ? II study assessing the safety and efficacy of intravenous ex-vivo cultured adult allogeneic mesenchymal stem cells in patients with chronic obstructive pulmonary disease
试验速览
- 阶段
- 2 期
- 状态
- Other
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.Patients must be diagnosed as central acinar emphysema.
- •3.Patient must have a post-bronchodilator FEV1 % predicted value ≥ 30% and 80%.
- •4.Patient must be above 35 years of age, of either sex
- •5.Female patients of childbearing age must be willing to use accepted methods of contraception during the course of the study
- •6.Patient must be a ex-smoker (quit smoking for ≥ 6 months), with a cigarette smoking history of ≥10 pack-years
- •7.Patient should have the ability to understand the requirements of the study, provide written informed consent, abide by the study requirements, and agree to return for required follow-up
- •8.Patients should be willing to give informed consent for VNTR test
- •Note: There is no upper age limit for this trial
排除标准
- •1.Patient has been diagnosed with asthma or other clinically relevant lung disease other than COPD (e.g. restrictive lung diseases, Sarcoidosis, active Tuberculosis inclusive of healed tuberculosis, Idiopathic pulmonary fibrosis, Bronchiectasis, or lung cancer)
- •2.Patient has a known history of α1-Antitrypsin deficiency
- •3.Patient has had exacerbation of COPD which required hospitalization / oral or parenteral steroids within 4 weeks of screening
- •4.Patient has documented (Doppler 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
- •5.Patient has initiated pulmonary rehabilitation within 3 months of screening
- •6.Patient has evidence of active malignancy, or prior history of active malignancy that has not been in remission for at least 5 years
- •7.Patient suffering from end stage of a disease.
- •8.Hb% less than 10 gm%, Serum Creatinine more than or equal to 1.5 mg%, Serum total bilirubin more than or equal to 2mg%, HbA1c more than 6%, leucocytosis (more than 11,000/cmm)
- •9.Women who are lactating or positive to pregnancy test.
- •10.Patients tested positive for antibodies to HIV, CMV, and HBsAg & VDRL and HCV RNA
- •11.Patient enrolled in any other study within 3 months of this study
- •12.Patient has clinically serious and/or unstable intercurrent infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Investigator, may be jeopardized by participation in this study or by the complications of this therapy.
研究者
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