A Phase 2 interventional study of The human Bone Marrow Mesenchymal Stem Cell (hBMMSC) injection and Lactated Ringer's Injection (crystalloid) in Autoimmune Pulmonary Alveolar Proteinosis, sponsored by Jiuzhitang Maker (Beijing) Cell Technology Co.,Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Jiuzhitang Maker (Beijing) Cell Technology Co.,Ltd. · Phase 2, Interventional, and Treatment
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The purpose of this multicenter, randomized, double-blind, placebo-controlled phase IIb clinical trial is to evaluate the efficacy and safety of intravenous hBMMSC injection in patients with autoimmune pulmonary alveolar proteinosis (aPAP).
Autoimmune pulmonary alveolar proteinosis (aPAP) is a rare lung disease for which there is no specific drug treatment. Currently, the standard treatment strategy for PAP is whole-lung lavage (WLL), which is invasive and has limited therapeutic efficacy. The purpose of this study is to evaluate the efficacy and safety of hBMMSC intravenous treatment in patients with aPAP. The clinical trial intends to involve 10 participants. The trial is expected to last approximately 3 years.
Jiuzhitang Maker (Beijing) Cell Technology Co.,Ltd. is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The hBMMSC injection will be administered by intravenous infusion.
Drug: The human Bone Marrow Mesenchymal Stem Cell (hBMMSC) injection
Lactated Ringer's Injection will be used as the comparator and administered by intravenous infusion.
Drug: Lactated Ringer's Injection (crystalloid)
The hBMMSC injection will be administered by intravenous infusion at a dose of 2.0 × 10⁶ cells/kg per administration. A total of 2 doses will be administered, with a 2-week interval between doses.
Lactated Ringer's Injection will be used as the comparator and administered by intravenous infusion at a volume of 2 mL/kg per administration. A total of 2 doses will be administered, with a 2-week interval between doses.
Alveolar-arterial difference in oxygen tension (A-aDO2)
The between-group difference in the change from baseline in the alveolar-arterial oxygen tension gradient (\[A-a\]DO₂) at Week 24, comparing the hBMMSC injection group with the placebo group.
Time frame: 24 weeks
Diffusing capacity of the lungs for carbon monoxide (DLCO, % predicted)
The between-group differences in the efficacy of hBMMSC injection versus placebo on the diffusing capacity of the lungs for carbon monoxide (DLCO, % predicted) at Weeks 24 and 48 after treatment
Time frame: 24 weeks/48 weeks
PaO₂
The between-group differences in PaO₂ at Weeks 24 and 48 after treatment, comparing the hBMMSC injection group with the placebo group
Time frame: 24 weeks/48 weeks
Oxygenation index
The between-group differences in oxygenation indexat Weeks 24 and 48 after treatment, comparing the hBMMSC injection group with the placebo group
Time frame: 24 weeks/48 weeks
Oxygen therapy requirements
The between-group difference in oxygen therapy requirements at Weeks 24 and 48 after treatment, comparing the hBMMSC injection group with the placebo group
Time frame: 24 weeks/48 weeks
Disease severity score (DSS)
The between-group differences in disease severity score (DSS) at Weeks 24 and 48 after treatment, comparing the hBMMSC injection group with the placebo group.Disease Severity Score (DSS) is a scoring system used to evaluate disease severity based on predefined clinical signs, symptoms, or pathological changes. a higher DSS indicates more severe disease, whereas a lower DSS indicates milder disease, with 0 typically representing no detectable disease.
Time frame: 24 weeks/48 weeks
6-minute walk test (6MWT)
The between-group differences in the 6-minute walk test (6MWT) results at Weeks 12, 24, and 48 after treatment, comparing the hBMMSC injection group with the placebo group
Time frame: 12/24/48 weeks
Cardiopulmonary exercise testing (CPET)
The between-group differences in the cardiopulmonary exercise testing (CPET) results at Weeks 12, 24, and 48 after treatment, comparing the hBMMSC injection group with the placebo group
Time frame: 12/24/48 weeks
Forced vital capacity (FVC)
The between-group differences in forced vital capacity (FVC) at Weeks 4, 24, and 48 after treatment, comparing the hBMMSC injection group with the placebo group
Time frame: 4/24/48 weeks
Forced expiratory volume in 1 second (FEV₁)
The between-group differences in forced expiratory volume in 1 second (FEV₁) at Weeks 4, 24, and 48 after treatment, comparing the hBMMSC injection group with the placebo group
Time frame: 4/24/48 weeks
Pulmonary lesions assessed by imaging
The between-group difference in changes in pulmonary lesions assessed by imaging at Weeks 24 and 48 after treatment, comparing the hBMMSC injection group with the placebo group
Time frame: 24/48 weeks
Proportion of patients whose disease progressed to requiring whole-lung lavage (WLL) during the study period and the interval to WLL
The between-group difference in the proportion of patients whose disease progressed to requiring whole-lung lavage (WLL) during the study period and the interval to WLL, comparing the hBMMSC injection group with the placebo group
Time frame: 96 weeks
Medical Research Council (mMRC) dyspnea scores
The between-group differences in modified Medical Research Council (mMRC) dyspnea scores at Weeks 4, 12, 24, and 48 after treatment, comparing the hBMMSC injection group with the placebo group. Modified Medical Research Council (mMRC) Dyspnea Scale is a questionnaire used to assess the severity of breathlessness and its impact on daily activities, particularly in patients with chronic obstructive pulmonary disease (COPD). The score ranges from 0 to 4, with Grade 0 indicating breathlessness only during strenuous exercise and Grade 4 indicating severe breathlessness that limits leaving the house or dressing. A higher mMRC score indicates more severe dyspnea and greater activity limitation
Time frame: 4/12/24 weeks
St. George's Respiratory Questionnaire (SGRQ) scores
The between-group differences in St. George's Respiratory Questionnaire (SGRQ) scores at Weeks 4, 12, 24, and 48 after treatment, comparing the hBMMSC injection group with the placebo group. The St. George's Respiratory Questionnaire (SGRQ) is a disease-specific questionnaire used to assess health-related quality of life in patients with respiratory diseases. The total score ranges from 0 to 100, where higher scores represent worse respiratory health status and greater impairment of quality of life.
Time frame: 4/12/24/48 weeks
The safety of hBMMSC injection
The safety of hBMMSC injection compared with placebo during Weeks 24 and 48, as assessed by the incidence of adverse events (AEs), serious adverse events (SAEs), adverse drug reactions (ADRs), important adverse events, and discontinuations due to AEs.
Time frame: 24/48 weeks
The proportion of patients with an improvement from baseline in [A-a]DO₂
The proportion of patients with an improvement from baseline in \[A-a\]DO₂ at Weeks 24 and 48 after treatment
Time frame: 24/48 weeks
The proportion of patients with an improvement from baseline in DLCO
The proportion of patients with an improvement from baseline in DLCO at Weeks 24 and 48 after treatment
Time frame: 24/48 weeks
The incidence of AEs and SAEs
The incidence of AEs and SAEs through Week 48 after treatment
Time frame: 48 weeks
The proportion of patients with improvements from baseline in PaO₂
The proportion of patients with improvements from baseline in PaO₂ at Weeks 24 and 48 after treatment
Time frame: 24/48 weeks
The proportion of patients with improvements from baseline in oxygenation index
The proportion of patients with improvements from baseline in oxygenation index at Weeks 24 and 48 after treatment
Time frame: 24/48 weeks
The proportion of patients with improvements from baseline in disease severity score (DSS)
The proportion of patients with improvements from baseline in disease severity score (DSS) at Weeks 24 and 48 after treatment
Time frame: 24/48 weeks
The proportion of patients with improvement in pulmonary lesions
The proportion of patients with improvement in pulmonary lesions as assessed by imaging at Weeks 24 and 48 after treatment
Time frame: 24/48 weeks
The between-group differences in peripheral capillary oxygen saturation (SpO₂)
The between-group differences in peripheral capillary oxygen saturation (SpO₂) at Weeks 4, 12, 24, and 48 after treatment, comparing the hBMMSC injection group with the placebo group
Time frame: 4/12/24/48 weeks
The proportion of patients with improvements in the 6-minute walk test (6MWT)
The proportion of patients with improvements in the 6-minute walk test (6MWT) results at Weeks 12, 24, and 48 after treatment
Time frame: 12/24/48 weeks
The proportion of patients with improvements in the cardiopulmonary exercise testing (CPET)
The proportion of patients with improvements in the cardiopulmonary exercise testing (CPET) results at Weeks 12, 24, and 48 after treatment
Time frame: 12/24/48 weeks
The change in serum anti-GM-CSF antibody levels
The between-group difference in the change from baseline in serum anti-GM-CSF antibody levels at Weeks 24 and 48 after treatment
Time frame: 24/48 weeks
The changes in body weight in the hBMMSC injection group compared to the placebo group
Time frame: 4/12/24/48 weeks
The changes in height in the hBMMSC injection group compared with the placebo group
Time frame: 4/12/24/48 weeks
The changes in blood pressure in the hBMMSC injection group compared with the placebo group
Time frame: 4/12/24/48 weeks
The changes in pulse rate in the hBMMSC injection group compared with the placebo group
Time frame: 4/12/24/48 weeks
The changes in body temperature in the hBMMSC injection group compared with the placebo group
Time frame: 4/12/24/48 weeks
The changes in complete blood count in the hBMMSC injection group compared with the placebo group
Time frame: 4/12/24/48 weeks
The changes in urinalysis in the hBMMSC injection group compared with the placebo group
Time frame: 4/12/24/48 weeks
Start is estimated for Oct 2026; primary completion for Oct 2029, 36 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Pulmonary Alveolar Proteinosis, Acquired
Jiuzhitang Maker (Beijing) Cell Technology Co.,Ltd.