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Clinical Recruitment: Patients with Autoimmune Pulmonary Alveolar Proteinosis
2024-08-20
Currently, a Phase IIa clinical trial evaluating human bone marrow mesenchymal stem cells for the treatment of autoimmune alveolar proteinosis is being conducted in collaboration between Jiuzhitang Maker (Beijing) Cell Technology Co., Ltd. and the Department of Respiratory Medicine at the First Affiliated Hospital of Guangzhou Medical University. The trial is now recruiting voluntary participants who have been diagnosed with autoimmune alveolar proteinosis to join this Phase IIa study.
01 Project Overview
This is an open-label Phase IIa clinical trial evaluating the safety and preliminary efficacy of human bone marrow mesenchymal stem cell injection for the treatment of autoimmune alveolar proteinosis.
The principal investigator of this project is Professor Shi Yue Li from the Department of Respiratory Medicine at the First Affiliated Hospital of Guangzhou Medical University. The investigational drug is an injection containing human bone marrow mesenchymal stem cells (hBMMSC), provided by Jiuzhitang Maker (Beijing) Cell Technology Co., Ltd. Please note that this product has not yet received regulatory approval for official market release. The study has been approved by the Ethics Committee of the First Affiliated Hospital of Guangzhou Medical University.
02 Recruitment Requirements
Participants must meet the following criteria to be eligible for the trial:
1. Male or female aged 18 years or older;
2. Patients diagnosed with autoimmune pulmonary alveolar proteinosis via CT, biopsy (TBLB, TBCB, or surgical lung biopsy), bronchoalveolar lavage (BAL), or by elevated GM-CSF autoantibodies in serum;
3. At least two results (with an interval of at least 3 months) from pre-enrollment CT scans, pulmonary function tests, or blood gas analyses indicated that the condition had not improved.
4. At rest and without supplemental oxygen, an arterial oxygen partial pressure (PaO2) ≤70 mmHg, or an oxygenation index ≤333 mmHg;
5. Participants of childbearing potential must use effective medical contraception (for both male and female participants, for up to one year after the last study drug administration);
6. Voluntarily sign the informed consent form.
Note: During your participation in the study, you will undergo a health checkup conducted by hospital specialists. You must meet all specified requirements and receive approval from the physician overseeing this research project before being eligible for enrollment. The final interpretation rests solely with the study department.
03 Contact Information
For detailed information about the trial, please consult the study doctor during business hours, from 8:30 a.m. to 5:30 p.m.
Contact and phone number for recruitment:
Teacher Han, 16738899349
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