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Clinical Efficacy and Safety of Autologous Lung Stem Cell Transplantation in Patients With Idiopathic Pulmonary Fibrosis

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ClinicalTrials.gov Identifier: NCT02745184
Recruitment Status : Recruiting
First Posted : April 20, 2016
Last Update Posted : September 12, 2018
Sponsor:
Collaborator:
Regend Therapeutics
Information provided by (Responsible Party):
Wei Zuo, Shanghai East Hospital

Brief Summary:
Idiopathic pulmonary fibrosis (IPF) is a chronic and ultimately fatal disease characterized by a progressive damage of lung structure and decline in lung function.This study intends to carry out an open, single-center, non-randomized, self control phase I clinical trial. During the treatment, lung stem cells will be isolated from patients' own bronchi and expanded in vitro. Cultured cells will be injected directly into the lesion by fiberoptic bronchoscopy after lavage. After twelve-month observation, the investigators will evaluate the safety and efficacy of the treatment by measuring the key clinical indicators.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Biological: Lung stem cells Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : April 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: lung stem cells
Patients will receive 10^6 (1 million)/Kg/person cells of clinical grade lung stem cells (LSCs)injected via fiberoptic bronchoscopy after fully lavage of the localized lesions.
Biological: Lung stem cells
Patients will receive 10^6 (1 million) /Kg/person cells of clinical grade lung stem cells (LSCs) injected via fiberoptic bronchoscopy after fully lavage of the localized lesions.




Primary Outcome Measures :
  1. Changes in forced vital capacity (FVC) [ Time Frame: 48 weeks ]
    To evaluate changes in FVC from baseline to 48 weeks


Secondary Outcome Measures :
  1. Changes in Forced expiratory volume in one second (FEV1) [ Time Frame: 48 weeks ]
  2. The differences of diffusing capacity of the lung for carbon monoxide (DLco) [ Time Frame: 48 weeks ]
  3. Changes in 6 minute walk distance (6MWD) [ Time Frame: 48 weeks ]
  4. Life quality: assessed by St. George respiratory questionnaire (SGRQ) [ Time Frame: 48 weeks ]
  5. Dyspnea score according by Modified Medical Research Center(MMRC) [ Time Frame: 48 weeks ]


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1)Written informed consent signed; 2)40<Age<=75 years; 3)Clinically diagnosed idiopathic pulmonary fibrosis(see 2011 guidance);

Exclusion Criteria:

  1. Allergic to cell therapy;
  2. Patients with serious significant pulmonary infection need anti-infection treatment;
  3. Patients who has taken amiodarone which may cause pulmonary fibrosis in the past 3 months;
  4. Patients with malignant tumor in the past 5 years;
  5. Participated in other clinical trials in the past 3 months;
  6. Patients with serious heart disease(NYHA class Ⅲ-Ⅳ), liver disease(ALT or AST 2 times above the upper level of normal value range), kidney disease(Cr above the upper level of normal value range);
  7. Pregnant or lactating women;
  8. The investigator assessed as inappropriate to participate in this clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02745184


Contacts
Contact: Tao Ren, M.D. rentao305@163.com
Contact: Wei Zuo, Ph.D. zuow@regend.cn

Locations
China, Jiangsu
Regend Therapeutics Recruiting
Suzhou, Jiangsu, China, 215123
Contact: Wei Zuo, Ph.D.       zuow@regend.cn   
Contact: Ting Zhang, Ph.D.       regendchina@hotmail.com   
Principal Investigator: Wei Zuo, Ph.D.         
Sub-Investigator: Ting Zhang, Ph.D.         
Sub-Investigator: Yu Ma, Ph.D.         
China, Shanghai
Shanghai East Hospital Recruiting
Shanghai, Shanghai, China, 200123
Contact: Tao Ren, M.D.       rentao305@163.com   
Contact: Lihua Bai, M.M.       tongjiyixue@126.com   
Principal Investigator: Tao Ren, M.D.         
Sponsors and Collaborators
Shanghai East Hospital
Regend Therapeutics

Publications:
Responsible Party: Wei Zuo, Professor, Shanghai East Hospital
ClinicalTrials.gov Identifier: NCT02745184     History of Changes
Other Study ID Numbers: 201602101
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial