Human Umbilical Cord Mesenchymal Stem Cell Injection for the Treatment of Interstitial Lung Disease

Shanghai Life Science & Technology

Status and phase: Begins enrollment in 3 months; Phase 1

Conditions: Interstitial Lung Disease

Treatments: Drug: Human umbilical cord mesenchymal stem cell injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06534528

SHLF-MSC-ILD-101

Details and patient eligibility

About

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).

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Dose escalation

Experimental group

Description:

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.

Treatment:

Drug: Human umbilical cord mesenchymal stem cell injection