A Study on Radiation-induced Pulmonary Fibrosis Treated With Clinical Grade Umbilical Cord Mesenchymal Stem Cells

NCT ID: NCT02277145

Last Updated: 2019-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2018-12-31

Brief Summary

Radiation therapy is one of the main means for treating malignant tumor, during which radioactive lung injury is inevitable. Currently there is nearly no effective clinical treatment for late post-radiotherapy pulmonary fibrosis. This study intends to carry out an open, single-center, non-randomized phase I clinical trial. During the treatment, the local lesions will be fully lavaged, and then clinical grade umbilical cord mesenchymal stem cells (MSCs) will be injected directly into the lesion by fiberoptic bronchoscopy. After six-month observation, the investigators will initially evaluate the safety and effectiveness of the treatment by measuring two key indicators-the CT density histogram and the patients' self-evaluation, and one secondary indicator-the changes of TGF-β1 contents, both before and after the treatment. Meanwhile, the investigators will make a preliminary discuss about the possible immunomodulatory effects of the umbilical cord MSCs.

Conditions

Post-radiotherapy Pulmonary Fibrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment group

Patients will receive 10\^6 (1 million) /Kg/person cells of clinical grade umbilical cord mesenchymal stem cells (MSCs) injected via fiberoptic bronchoscopy after fully lavage of the localized lesions

Group Type: EXPERIMENTAL

clinical grade umbilical cord mesenchymal stem cells

Intervention Type: BIOLOGICAL

10\^6 (1 million) /Kg/person cells of clinical grade umbilical cord MSCs will be injected after fully lavage of the localized lesions

Interventions

clinical grade umbilical cord mesenchymal stem cells

10\^6 (1 million) /Kg/person cells of clinical grade umbilical cord MSCs will be injected after fully lavage of the localized lesions

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Male or female, 18-70 years old.

2. Subjects with a clear history of malignancy.

3. Subjects with a clear history of chest radiation therapy at least 3 months earlier.

4. Subjects diagnosed as chronic phase of radiation-induced pneumonitis or radiation-induced pulmonary fibrosis stage (see Annex 3 for diagnosis).

5. Subjects signed informed consent.

Exclusion Criteria

1. Women of childbearing age at the stage of pregnancy or lactation, or those without taking effective contraceptive measures.

2. Subjects with syphilis or HIV positive antibody.

3. Subjects with infection aggravated within the past month.

4. Subjects suffering from any of the following pulmonary diseases: active tuberculosis, pulmonary embolism, pneumothorax, multiple huge bullae, uncontrolled asthma, severe pneumonia, acute exacerbation of chronic bronchitis, AECOPD, severe and / or extremely severe COPD, etc..

5. Subjects suffering from other serious diseases, such as myocardial infarction, unstable angina, cirrhosis, and acute glomerulonephritis.

6. Subjects with progression-free survival (PFS) less than 0.5 years or Karnofsky performance scores less than 60 points.

7. Subjects with leukopenia (WBC less than 4x109 / L) or agranulocytosis (WBC less than 1.5x109 / L or neutrophils less than 0.5x109 / L) caused by any reason.

8. Subjects with severe renal impairment, serum creatinine> 1.5 times the upper limit of normal.

9. Subjects with liver disease or liver damage: ALT, AST, total bilirubin> 2 times the upper limit of normal

10. Subjects with a history of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders.

11. Subjects with severe arrhythmias (such as ventricular tachycardia, frequent superventricular tachycardia, atrial fibrillation, and atrial flutter, etc.) or cardiac degree II or above conduction abnormalities displayed via 12-lead ECG.

12. Subjects with a history of alcohol or illicit drug abuse.

13. Subjects accepted by any other clinical trials within 3 months before the enrollment

14. Subjects with poor compliance, difficult to complete the study.

15. Any other conditions that might increase the risk of subjects or interfere with the clinical trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southwest Hospital, China

OTHER

Sponsor Role: collaborator

Jianwu Dai

OTHER_GOV

Sponsor Role: lead

Responsible Party

Jianwu Dai

Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

JianWu Dai, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Sciences

Wei Xiong, M.D

Role: STUDY_CHAIR

First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital)

Xiaotian Dai, M.M

Role: STUDY_DIRECTOR

First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital)

Locations

First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital)

Chongqing, Chongqing Municipality, China

Countries

China

Other Identifiers

CAS-XDA001-SH/IGDB

Identifier Type: -

Identifier Source: org_study_id