Status:
NOT_YET_RECRUITING
Human Umbilical Cord Mesenchymal Stem Cell Injection for the Treatment of Interstitial Lung Disease
Lead Sponsor:
Shanghai Life Science & Technology
Conditions:
Interstitial Lung Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06534528
Start Date
October 1 2025
End Date
October 1 2027
Last Update
May 25 2025
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