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

Launched by SHANGHAI LIFE SCIENCE & TECHNOLOGY · Jul 30, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for interstitial lung disease (ILD), which is a group of conditions that cause scarring in the lungs and can make it hard to breathe. The researchers want to find out if injecting human umbilical cord stem cells is safe and tolerable for patients with ILD. They also hope to learn how effective this therapy might be and to determine the best dose for future studies.

To participate in this trial, you need to be at least 18 years old and have a clinical diagnosis of ILD. Some important health criteria must be met, including certain levels of liver and kidney function tests. However, if you have used high doses of certain medications recently, have had specific lung issues, or have other serious health conditions, you may not be eligible. Participants will be closely monitored throughout the trial to ensure their safety. This study is still in the planning stage and has not started recruiting participants yet.

Gender

ALL

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;