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Phase I/IIa Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cell Injection in the Treatment of Idiopathic Pulmonary Fibrosis (IPF)
Study Purpose
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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
No
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Interventional
Eligible Ages
50 Years - 75 Years
Gender
All
More Inclusion & Exclusion Criteria
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.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Phase 1
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
Shanghai Life Science & Technology
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study.
N/A
Principal Investigator Affiliation
N/A
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
Industry
Overall Status
Recruiting
Countries
China
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied.
Idiopathic Pulmonary Fibrosis
Arms & Interventions
Arms
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.
Interventions
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.
Contact a Trial Team
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International Sites
Shanghai Sixth People's Hospital, Shanghai, Shanghai, China