Efficacy and safety of CAStem cell injection in the treatment of acute exacerbation of interstitial lung disease (AE-ILD)

• Register: ChiCTR
• Last refreshed on: 4 March 2024
• Main ID: ChiCTR2400081256
• Date of registration: 2024-02-27
• Prospective Registration: No
• Primary sponsor: China-Japan Friendship Hospital
• Public title: Efficacy and safety of CAStem cell injection in the treatment of acute exacerbation of interstitial lung disease (AE-ILD)
• Scientific title: Efficacy and safety of CAStem cell injection in the treatment of acute exacerbation of interstitial lung disease (AE-ILD)
• Date of first enrolment: 2023-09-21
• Target sample size: Experimental drug low dose group:15;Experimental drug high dose group:15;Placebo control group:15;
• Recruitment status: Recruiting
• URL: https://www.chictr.org.cn/showproj.html?proj=201722
• Study type: Interventional study
• Study design: Dose comparison
• Phase: 2

Countries of recruitment

China

Contacts

• Name: Chen Fangyan
• Affiliation: Zephyrm Biotechnologies

• Name: Huaping Dai
• Affiliation: China-Japan Friendship Hospital

Key inclusion & exclusion criteria

Inclusion criteria: 1) Age =18 years, =75 years;
2) For those who have been diagnosed with ILD or are currently diagnosed with acute respiratory exacerbation, the following three criteria are met:
? The time of acute respiratory deterioration is usually less than 1 month;
(2) Chest HRCT confirmed the appearance of new diffuse ground glass shadows and/or solid shadows of both lungs on the background of fibrotic ILD manifestations such as reticular shadows or honeycomb shadows or tractable bronchiectasis;
The worsening of dyspnea could not be explained by heart failure or fluid overload;
3) Voluntarily participate in this study, agree to comply with the requirements of the clinical trial protocol, and sign the informed consent.
Exclusion criteria:
1: Have a history of severe allergy or allergy to the main active ingredient or excipient of the drug, such as human blood albumin or dimethyl sulfoxide (DMSO)
2: Patients who had a history of AE-ILD within the past 3 months and were considered unfit to participate in the study
3: Currently suffering from severe pneumothorax or massive pleural effusion
4: WHO grade III or IV pulmonary hypertension
5: Pulmonary embolism has been diagnosed
6: Currently has arrhythmia affecting hemodynamics
7: Patients undergoing mechanical ventilation with tracheal intubation
8: Patients undergoing extracorporeal membrane oxygenation (ECMO), continuous kidney replacement therapy (CRRT), polymyxin-B fixed fiber hemoperfusion (PMX-DHP), plasma exchange and other forms of extracorporeal life support
9: Prospective lung transplant recipients in the near future
10: Patients with connective tissue disease or systemic vasculitis
11: Patients with other serious chronic respiratory diseases, such as chronic obstructive pulmonary disease, bronchial asthma, bronchiectasis, etc., or current PaCO2 >50mmHg associated with any cause, and the investigators believe that it is not appropriate to participate in this study
12: People with primary immunodeficiency
13: Patients with a history of malignant tumor or severe atypical hyperplasia without treatment
14: Currently have active infectious diseases, including but not limited to human immunodeficiency virus (HIV) antibody positive, active tuberculosis, etc., and the investigator considers it inappropriate to participate in this study
15: Body mass index (BMI) =35 kg/m2
16: Those who have received immune cell therapy within 3 months
17: Organ transplant patients requiring immunosuppressive therapy
18: Women who are pregnant or nursing or plan to become pregnant during the study, or women or men of childbearing age who are not willing to use contraception throughout the trial
19: Use of another investigational drug within 28 days prior to initiation of treatment, and the investigational drug in question is determined by the investigator to interfere with the evaluation of the safety and efficacy of the investigational drug
20: The investigator considered that participation in this study was not in the best interest of the subjects or was not suitable for other circumstances, such as poor compliance.

Age minimum: 18
Age maximum: 75
Gender: Both

Health Condition(s) or Problem(s) studied

Acute exacerbation of interstitial lung disease

Intervention(s)

Experimental drug low dose group:Basic treatment +CAStem cells 1×10^6 cells /kg, intravenous infusion, once a week, a total of 3 times;Experimental drug high dose group:Basic treatment +CAStem cells 3×10^6 cells /kg, intravenous infusion, once a week, a total of 3 times;Placebo control group:Basic treatment + placebo injection, intravenous infusion, once a week, a total of 3 times;

Primary Outcome(s)

mortality of 3 months;

Secondary Outcome(s)

The recurrence rate of AE, the time of first AE recurrence after medication, and the number of AE recurrence;PaO2, oxygenation index, P (A-a) O2 change from baseline;Changes in chest HRCT scores improve from baseline;Improvement in lung function;Improvement in 6-MWT ;mMRCimprovement from baseline;Improvement in SGRQ scores;mortality ;Clinical benefits of composite indicators of adverse outcomes(invasive ventilation through tracheal intubation, ECMO, lung transplantation);

Source(s) of Monetary Support

sponsor (Zephyrm Biotechnologies)

Ethics review

Status: Approved
Approval date: 02/06/2023
Contact:

Zhou Wei

[phone]