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Autologous Lung Stem Cell Transplantation in Patients With Interstitial Lung Diseases

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ClinicalTrials.gov Identifier: NCT02796781
Recruitment Status : Recruiting
First Posted : June 13, 2016
Last Update Posted : October 9, 2017
Sponsor:
Collaborator:
Regend Therapeutics
Information provided by (Responsible Party):
Wei Zuo, Shanghai East Hospital

Brief Summary:
Interstitial lung diseases (ILD) are a group of diseases affecting the lung interstitium. The lung scarring that occurs in ILD is often irreversible with only mitigating therapy available so far. This study intends to carry out an open, single-armed, phase I/II clinical trial to investigate whether lung stem cells can regenerate damaged lung tissue. During the treatment, lung stem cells will be isolated from patients' own bronchi and expanded in vitro. After careful characterization, cultured cells will be injected directly into the lesion by fiberoptic bronchoscopy. The safety and efficacy of the treatment will be monitored by measuring the key clinical indicators.

Condition or disease Intervention/treatment Phase
Interstitial Lung Diseases Biological: Lung stem cells Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


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 into lung via fiberoptic bronchoscopy.
Biological: Lung stem cells



Primary Outcome Measures :
  1. Increase of diffusing capacity of the lung for carbon monoxide (DLCO) [ Time Frame: 3~48 weeks ]

Secondary Outcome Measures :
  1. Increase of total lung capacity (TLC) [ Time Frame: 3~48 weeks ]
  2. Increase in 6 minute walk distance (6MWD) [ Time Frame: 3~48 weeks ]
  3. Life quality: assessed by St. George respiratory questionnaire (SGRQ) [ Time Frame: 3~48 weeks ]


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with interstitial lung disease
  • Clinically stable
  • Written informed consent signed

Exclusion Criteria:

  • Allergic to cell therapy;
  • Patients with serious significant pulmonary infection need anti-infection treatment;
  • Patients who has taken amiodarone which may cause pulmonary fibrosis in the past 3 months;
  • Patients with malignant tumor in the past 5 years;
  • Participated in other clinical trials in the past 3 months;
  • Patients with serious heart disease(NYHA class Ⅲ-Ⅳ)
  • Pregnant or lactating women;
  • 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): NCT02796781


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: NCT02796781     History of Changes
Other Study ID Numbers: 201602102
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases