dermatomyositis
Conditions
Interventions
group 1:routine treatment combined with aerosol inhalation of allogenic adipose MSC-Exos group
group 2:routine treatment combined with intravenous injection of allogenic adipose MSC-Exos group
group 3: routine treatment combined with aerosol inhalation and intravenous injection of allogenic adipose MSC-Exos group
group 4:routine treatment
Sponsors
Rui Jin Hospital, School of Medicine, Shanghai Jiao Tong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Participants or guardians are fully aware of the trial and are willing to participate in the trial and sign the informed consent. 2. Aged 18-75 years old, male or female; 3. diagnosed as "MDA5 antibody positive dermatomyositis with interstitial lung disease (ILD)". The following conditions must be met at the same time: a) DM was diagnosed based on the criteria of Bohan and Peter and CADM diagnosis followed the modified Sontheimer definition;disease duration less than 3 months; b) anti-MDA5 antibody positive; c) interstitial lung disease meet the Akira diagnostic criteria: i. Progressive dyspnea aggravates in recent 1 month; ii.Chest CT indicates new ground glass shadow or nodule; iii. hypoxia. Partial pressure of blood oxygen (PaO2) decreased >= 10 mmHg; iv. Exclusion of pulmonary infection. v. Exclusion of pulmonary embolism, pneumothorax,congestive heart failure,etc. 4. Immunosuppressants (including but not limited to cyclophosphamide, azathioprine, tacrolimus, methotrexate, leflunomide, etc.) or biological agents (including ,not limited to rituximab, infliximab, adalimumab, etanercept, etc. have not been used.
Exclusion criteria
Exclusion criteria: 1. Patients with severe allergic constitution. 2. Patients with uncontrolled moderate and severe heart, liver, kidney and other diseases. 3. Patients with malignant tumors (including past or present diseases). 4. Patients with neuromuscular diseases that lead to impaired natural ventilation, including, but not limited to, C5 or higher spinal cord injury, amyotrophic lateral sclerosis, Guillain-Barre syndrome and myasthenia gravis. 5. Patients with other connective tissue diseases. 6. Patients with lung transplantation. 7. Patients with bone marrow transplantation. 8. Patients with a history of epilepsy, with continuous anticonvulsant therapy, or have received anticonvulsant therapy in the past 3 years. 9. The estimated survival time is less than 30 days. 10. Patients and carriers of pulmonary tuberculosis, hepatitis B, hepatitis C, AIDS and syphilis. 11. Women of childbearing age are pregnant, lactating or planning to conceive within nearly one year. 12. According to the researchers, there are other conditions that the patients are not suitable to participate in the study (such as factors that may reduce follow-up compliance, and patients do not receive relevant supportive treatment, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Drug Reaction;Survival rate;Treatment Emergent Adverse Event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival rate;Treatment Emergent Adverse Event; | — |
Countries
China
Contacts
Public ContactChengde Yang
Department of Rheumatology and Immunology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed