Phase I/IIa Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cell Injection in the Treatment of Idiopathic Pulmonary Fibrosis (IPF)

April 24, 2024 updated by: Shanghai Life Science & Technology

An Open Clinical Study to Explore the Safety, Tolerance and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell Injection in the Treatment of Idiopathic Pulmonary Fibrosis (IPF)

Main purpose

-To explore the safety and tolerance of human umbilical cord mesenchymal stem cells in the treatment of idiopathic pulmonary fibrosis (IPF).

Secondary purpose

  • To explore the preliminary efficacy of human umbilical cord mesenchymal stem cells in the treatment of idiopathic pulmonary fibrosis (IPF), and to recommend the appropriate dose of cell therapy for subsequent clinical studies.
  • To explore the immunogenicity of human umbilical cord mesenchymal stem cell injection in the treatment of idiopathic pulmonary fibrosis (IPF).

This study adopts a clinical research design of multi center, single dose and increasing dose.

18 qualified IPF subjects will be included in this study.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200233
        • Recruiting
        • Shanghai Sixth People's Hospital
        • Contact:
        • Principal Investigator:
          • Song Yuanlin, Doctor of Medicine
        • Principal Investigator:
          • Li Feng, Doctor of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • (1) Age 50~75 years old (including the threshold), regardless of gender;

    (2) IPF was diagnosed according to the diagnostic guidelines for idiopathic pulmonary fibrosis jointly issued by the American Thoracic Society (ATS), the European Respiratory Society (ERs), the Japanese Respiratory Society (JRS) and the Latin American Thoracic Association (ALAT) in 2018;

    (3) Subjects with typical imaging manifestations of IPF (honeycomb, stretch bronchiectasis or bronchiectasis (mainly in ground glass shadow and fine mesh shadow) on HRCT within 12 months before screening;

    (4) Within 3 months before administration, the researcher determined that the disease was stable. The pulmonary carbon monoxide diffusion volume (DLCO) was 30% - 79% of the predicted value (corrected by HB value), or FVC was 50% - 80% of the predicted value;

    (5) Blood biochemical examination should meet the following standards: alanine aminotransferase (ALT) ≤ 1.5uln, aspartate aminotransferase (AST) ≤ 1.5uln, total bilirubin (TBIL) ≤ 1.5uln, direct bilirubin (DBIL) ≤ 1.5uln, blood creatinine (CR) ≤ 1.5uln;

    (6) Expected survival ≥ 12 months;

    (7) Subjects who have good compliance, can understand and cooperate with the completion of pulmonary function examination, are willing to take drugs according to the requirements of the protocol and receive follow-up examination on time;

    (8) Subjects who voluntarily participated in the trial, understood and signed the informed consent form.

Exclusion Criteria:

  • (1) Have previously received stem cell therapy, or are intolerant to cell therapy, or have taken drugs that may cause or aggravate pulmonary fibrosis (such as amiodarone, bleomycin or methotrexate);

    (2) Suffering from interstitial lung disease (ILD) other than IPF, including but not limited to: any other type of interstitial pneumonia; Lung disease related to exposure to fibroblasts or other environmental toxins or drugs; Other types of occupational lung disease; Granulomatous pulmonary disease; Pulmonary vascular disease; Systemic diseases, including vasculitis, infectious diseases (i.e. tuberculosis) and connective tissue diseases;

    (3) Those who need oxygen therapy at present (oxygen therapy time 15h/d);

    (4) Those who used or planned to use nidanib during the study 1 month before screening;

    (5) Subjects with a history of mechanical ventilation or complicated with infectious pneumonia and asthma within 1 month before screening;

    (6) Patients with malignant tumors within 5 years before screening;

    (7) Those who have been hospitalized for 3 times or more due to acute exacerbation of IPF or other respiratory diseases within 1 year before screening;

    (8) There is evidence that the subjects currently have digestive, urinary, cardiovascular, cerebrovascular, hematological, nervous, mental and metabolic diseases that may affect safety, such as type 2 diabetes with poor blood glucose control (fasting blood glucose ≥ 10.0mmol/l or HbA1c ≥ 8.0%), hypertension with poor blood pressure control (≥ 160/100mmhg), etc;

    (9) Have a history of psychotropic drug abuse and drug abuse;

    (10) People with known history of immune system (such as thymus disease and systemic lupus erythematosus);

    (11) Patients with positive serum Virology (HBsAg, HCV antibody, HIV antibody, Treponema pallidum antibody), including hepatitis B virus carriers, patients with stable hepatitis B after drug treatment (DNA titer ≤ 500iu/ml or copy number < 1000copies/ml) and cured patients with hepatitis C (HCV RNA test negative) can be enrolled after being judged to be qualified by the researcher;

    (12) People who are allergic to human albumin, narcotic drugs or their ingredients;

    (13) Subjects who participated in any other clinical trials within the first 3 months of screening;

    (14) Subjects who cannot tolerate bronchoscopy (including but not limited to the following conditions: active massive hemoptysis; severe hypertension and arrhythmia; myocardial infarction or history of unstable angina pectoris within 4-6 weeks before screening; severe cardiopulmonary dysfunction; uncorrectable bleeding tendency (platelet count < 60 × 109/l), such as severe coagulation dysfunction, uremia and severe pulmonary hypertension; Severe superior vena cava obstruction syndrome; Suspected aortic aneurysm; Multiple pulmonary bullae; General condition (extreme failure);

    (15) The researchers judged that the risk of general anesthesia / local anesthesia was higher;

    (16) Human chorionic gonadotrophin in pregnancy or lactation, or screening β （ β- HCG) positive, or unable and unwilling to take effective non drug contraceptives during the study period and 6 months after the end of the study;

    (17) Other circumstances that the researcher believes are not suitable for entering this test.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose escalation
Four different doses were set, and three subjects in each dose plan received human umbilical cord mesenchymal stem cell injection successively. Each subject received a single dose of 6.0*10^6, 3.0*10^7, 6.0*10^7, and 9.0*10^7 cells / person.
Drug: Human umbilical cord mesenchymal stem cell injection
Different doses of human umbilical cord mesenchymal stem cell injection were infused to the focus of patients with idiopathic pulmonary fibrosis through bronchoscope, and the tolerance of subjects to different doses of human umbilical cord mesenchymal stem cell injection was observed, and the curative effect was preliminarily observed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerance of patients with idiopathic fibrosis to human umbilical cord mesenchymal stem cell injection
Time Frame: From the first administration to 4 weeks after administration
Incidence and severity of adverse events according to CTCAE5.0
From the first administration to 4 weeks after administration
Dose exploration of patients with idiopathic fibrosis to human umbilical cord mesenchymal stem cell injection
Time Frame: From the first administration to 4 weeks after administration

The maximum tolerable dose (MTD) of a single administration depends on whether dose limiting toxicity (DLT) occurs within 4 weeks after the first administration, for example (1) Hematological toxicity of grade 3 and above caused by the treatment of human umbilical cord mesenchymal stem cell injection,

（2） There are grade 3 and above non hematological toxic reactions caused by the treatment of human umbilical cord mesenchymal stem cell injection, except for the following cases, (3) Any other toxicity related to cell therapy that is higher than the baseline level is judged as clinically significant and / or unacceptable by the investigator and the sponsor, (4) There are acute exacerbations and serious adverse events (SAE) of IPF related to the treatment of human umbilical cord mesenchymal stem cell injection (which may be related, likely to be related and definitely related)
From the first administration to 4 weeks after administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preliminary efficacy evaluation
Time Frame: The 4th, 12th, 24th and 48th week after administration
Changes from baseline in St. George's respiratory questionnaire SGRQ, dyspnea score, cough score and 6-minute walk test (grade and distance)in the treatment of idiopathic pulmonary fibrosis (IPF), and to recommend the appropriate dose of cell therapy for subsequent clinical studies
The 4th, 12th, 24th and 48th week after administration
Preliminary efficacy evaluation
Time Frame: The 4th, 12th, 24th and 48th week after administration
Changes in lung function (FVC, DLCO sb) compared with baseline
The 4th, 12th, 24th and 48th week after administration

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preliminary efficacy evaluation
Time Frame: The 4th, 12th, 24th and 48th week after administration
Changes in abnormal values of routine safety tests (blood routine, urine routine, blood biochemistry, 12 lead ECG, etc.) compared with baseline
The 4th, 12th, 24th and 48th week after administration
Preliminary efficacy evaluation
Time Frame: The 12th, 24th and 48th week after administration
Changes in chest HRCT scores from baseline
The 12th, 24th and 48th week after administration
Preliminary efficacy evaluation
Time Frame: The 12th, 24th and 48th week after administration
Changes of lung tumor markers from baseline
The 12th, 24th and 48th week after administration
Preliminary efficacy evaluation
Time Frame: Within 48 weeks after administration
Frequency and severity of acute exacerbations of IPF
Within 48 weeks after administration
Immunogenicity of human umbilical cord mesenchymal stem cells
Time Frame: The 1st and 4th weeks after administration
Changes of specific immunoglobulin G (IgG) from baseline
The 1st and 4th weeks after administration
Immunogenicity of human umbilical cord mesenchymal stem cells
Time Frame: The 1st and 4th weeks after administration
Cytokines (TNF- α、 IFN- γ、 Changes of IL-2, IL-4, IL-5 and IL-6) from baseline
The 1st and 4th weeks after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Life Science & Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2022

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

July 12, 2022

First Submitted That Met QC Criteria

July 19, 2022

First Posted (Actual)

July 21, 2022

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHLF-MSC-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided: It is not yet known if there will be a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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