A clinical trial to study the effect of different doses of stem cells in Chronic Obstructive Pulmonary Disease

Phase 2

• Conditions: Health Condition 1: null- Chronic Obstructive Pulmonary Disease

• Registration Number: CTRI/2011/08/001936
• Lead Sponsor: Stempeutics Research Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 0

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.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

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 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The type of AE(s), number of AE(s) and proportion of patients with AE(s)Timepoint: 2 years

Secondary Outcome Measures

Name	Time	Method
Change from baseline in: <br/ ><br>â?¢Improvement in pulmonary function tests from baseline <br/ ><br>â?¢Improvement in exercise capability from baseline (six minute walk test) <br/ ><br>â?¢Improvement in quality of life Index (St. Georges respiratory questionnaire) <br/ ><br>â?¢Reduction in number of exacerbations/hospitalizations due to COPD <br/ ><br>â?¢Radiological improvement in High resolution computerized tomography of chest (HRCT) <br/ ><br>Timepoint: 1 year