Clinical trial NCT06534528: Human Umbilical Cord Mesenchymal Stem Cell Injection for the Treatment of Interstitial Lung Disease
Official title: An Open Clinical Study Exploring the Safety, Tolerability, and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell Injection in the Treatment of Interstitial Lung Disease (ILD)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Interstitial Lung Disease
Keywords: Interstitial Lung Disease
ILD
Lead sponsor: Shanghai Life Science & Technology
Sponsor class: INDUSTRY
First posted: 2024-08-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Dose1 Group：6.0×10\^6 cells/person, single-dose Dose2 Group：3.0×10\^7 cells/person, single-dose Dose3 Group：6.0×10\^7 cells/person, single-dose Dose4 Group：9.0×10\^7 cells/person, single-dose
Primary purpose: TREATMENT

Brief summary: Main objective: To explore the safety and tolerability of human umbilical cord mesenchymal stem cell injection in the treatment of interstitial lung disease (ILD); Secondary objective: To explore the preliminary effectiveness of human umbilical cord mesenchymal stem cell therapy for interstitial lung disease (ILD) and recommend appropriate cell therapy doses for subsequent clinical studies; Exploring the immunogenicity of human umbilical cord mesenchymal stem cell injection in the treatment of interstitial lung disease (ILD).


Eligibility criteria: Inclusion Criteria:

* Gender not limited, age ≥ 18 years old (including threshold);
* Clinical diagnosis of interstitial lung disease;
* Blood biochemistry tests must meet the following criteria: alanine aminotransferase (ALT) ≤ 2.5 × ULN, aspartate aminotransferase (AST) ≤ 2.5 × ULN, total bilirubin (TBIL) ≤ 2 × ULN, direct bilirubin (DBIL) ≤ 1.5 × ULN, or creatinine (Cr) ≤ 3 × ULN;
* The diffusion capacity of carbon monoxide (DLCO) (corrected by Hb) in lung function tests within the previous 3 months is 30% to 80% of the expected value (including 30% and 80%); Forced vital capacity (FVC) is 40% to 70% of the estimated value (including 40% and 70%)

Exclusion Criteria:

* Within the first 3 days of enrollment, use high-dose corticosteroids (equivalent to methylprednisolone\>240 mg/day) or irregularly use systemic corticosteroids;
* For patients receiving immunosuppressive therapy, unstable background treatment with cyclophosphamide, mycophenolate mofetil/sodium, methotrexate, or other immunosuppressive monotherapy is not allowed (combination therapy is not allowed)
* Diagnose IPF patients who have previously taken drugs that may cause or worsen pulmonary fibrosis;
* Individuals with a history of mechanical ventilation or concurrent infectious pneumonia or asthma within the previous month prior to screening; Patients with airway obstruction disease (FEV1/FVC\<0.7 before using bronchodilators); Patients with other clinically significant serious abnormalities in the lungs; Currently requiring oxygen therapy treatment (oxygen therapy time\>15h/d);
* Pregnant and lactating women
* Screening for malignant tumors that have occurred within the past 5 years, excluding cervical carcinoma in situ, squamous cell carcinoma of the skin, or basal cell carcinoma that have been previously treated for curative purposes;
* Individuals who have been hospitalized for 3 or more times due to acute exacerbation of ILD or other respiratory diseases within the past year prior to screening
* There is evidence that subjects currently have digestive system, urinary system, cardio cerebrovascular, blood system, nervous system, mental and metabolic diseases that may affect safety, such as type 2 diabetes with poor blood sugar control, hypertension with poor blood pressure control, etc
* have a history of abuse or drug use of psychotropic substances
* individuals allergic to human serum albumin, anesthetics, or their components
* Select participants who have participated in any other clinical trials within the previous 3 months;
* individuals who have previously received stem cell therapy
* Researchers have determined that the expected survival period may be less than 1 year;
* Subjects who cannot tolerate bronchoscopy examination (including but not limited to: active massive hemoptysis; severe hypertension and arrhythmia;

Primary outcomes:
measure: Maximum tolerated dose per dose (MTD)
timeFrame: From the first administration to 4 weeks after administration
Secondary outcomes:
measure: Preliminary efficacy evaluation：lung function
timeFrame: The 4th, 12th, 24th week after administration
measure: Preliminary efficacy evaluation: St. George's respiratory questionnaire(SGRQ)
timeFrame: The 4th, 12th, 24th week after administration
measure: Preliminary efficacy evaluation: dyspnea score
timeFrame: The 4th, 12th, 24th week after administration
measure: Preliminary efficacy evaluation: cough score
timeFrame: The 4th, 12th, 24th week after administration
measure: Preliminary efficacy evaluation: 6-minute walk test
timeFrame: The 4th, 12th, 24th week after administration
measure: Preliminary efficacy evaluation: Frequency of acute exacerbation events
timeFrame: The 4th, 12th, 24th week after administration
measure: Preliminary efficacy evaluation: High Resolution Computed Tomography scores(HRCT score)
timeFrame: The 4th, 12th, 24th week after administration
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]：Blood pressure
timeFrame: The 4th, 12th, 24th week after administration
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]：Pulse
timeFrame: The 4th, 12th, 24th week after administration
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]：respiration rate
timeFrame: The 4th, 12th, 24th week after administration
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]：body temperature
timeFrame: The 4th, 12th, 24th week after administration
measure: Blood routine
timeFrame: The 4th, 12th, 24th week after administration
measure: Blood biochemistry
timeFrame: The 4th, 12th, 24th week after administration
measure: Blood gas analysis
timeFrame: The 4th, 12th, 24th week after administration
measure: Concentration of Lung tumor markers
timeFrame: The 4th, 12th, 24th week after administration
measure: Electrocardiogram
timeFrame: The 4th, 12th, 24th week after administration
Other outcomes:
Locations:
Study officials:
References:
citation: Maher TM. Interstitial Lung Disease: A Review. JAMA. 2024 May 21;331(19):1655-1665. doi: 10.1001/jama.2024.3669.
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citation: Chambers DC, Enever D, Ilic N, Sparks L, Whitelaw K, Ayres J, Yerkovich ST, Khalil D, Atkinson KM, Hopkins PM. A phase 1b study of placenta-derived mesenchymal stromal cells in patients with idiopathic pulmonary fibrosis. Respirology. 2014 Oct;19(7):1013-8. doi: 10.1111/resp.12343. Epub 2014 Jul 9.
citation: Glassberg MK, Minkiewicz J, Toonkel RL, Simonet ES, Rubio GA, DiFede D, Shafazand S, Khan A, Pujol MV, LaRussa VF, Lancaster LH, Rosen GD, Fishman J, Mageto YN, Mendizabal A, Hare JM. Allogeneic Human Mesenchymal Stem Cells in Patients With Idiopathic Pulmonary Fibrosis via Intravenous Delivery (AETHER): A Phase I Safety Clinical Trial. Chest. 2017 May;151(5):971-981. doi: 10.1016/j.chest.2016.10.061. Epub 2016 Nov 24.