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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02745184
Recruitment Status : Recruiting
First Posted : April 20, 2016
Last Update Posted : March 26, 2020
Sponsor:
Collaborator:
Regend Therapeutics
Information provided by (Responsible Party):
Wei Zuo, Shanghai East Hospital

Tracking Information
First Submitted Date  ICMJE April 15, 2016
First Posted Date  ICMJE April 20, 2016
Last Update Posted Date March 26, 2020
Actual Study Start Date  ICMJE April 2016
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2016)
Changes in forced vital capacity (FVC) [ Time Frame: 48 weeks ]
To evaluate changes in FVC from baseline to 48 weeks
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2016)
  • Changes in Forced expiratory volume in one second (FEV1) [ Time Frame: 48 weeks ]
  • The differences of diffusing capacity of the lung for carbon monoxide (DLco) [ Time Frame: 48 weeks ]
  • Changes in 6 minute walk distance (6MWD) [ Time Frame: 48 weeks ]
  • Life quality: assessed by St. George respiratory questionnaire (SGRQ) [ Time Frame: 48 weeks ]
  • Dyspnea score according by Modified Medical Research Center(MMRC) [ Time Frame: 48 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Efficacy and Safety of Autologous Lung Stem Cell Transplantation in Patients With Idiopathic Pulmonary Fibrosis
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Pulmonary Fibrosis
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Biological: Lung stem cells
Publications * Zuo W, Zhang T, Wu DZ, Guan SP, Liew AA, Yamamoto Y, Wang X, Lim SJ, Vincent M, Lessard M, Crum CP, Xian W, McKeon F. p63(+)Krt5(+) distal airway stem cells are essential for lung regeneration. Nature. 2015 Jan 29;517(7536):616-20. doi: 10.1038/nature13903. Epub 2014 Nov 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 15, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tao Ren, M.D. rentao305@163.com
Contact: Wei Zuo, Ph.D. zuow@regend.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02745184
Other Study ID Numbers  ICMJE 201602101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wei Zuo, Shanghai East Hospital
Study Sponsor  ICMJE Shanghai East Hospital
Collaborators  ICMJE Regend Therapeutics
Investigators  ICMJE Not Provided
PRS Account Shanghai East Hospital
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP