Clinical study for the efficacy and safety of human muscle stem cells in the treatment of muscular dystrophy

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR1900024670

Enrollment

Unknown

Registered

2019-07-20

Start date

2019-10-01

Completion date

Unknown

Last updated

2019-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

progressive muscular dystrophy

Interventions

Case series:Multi-point injection of muscle from human muscle stem cells

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. meet the diagnostic criteria of progressive muscular dystrophy; 2. Aged 7-25 years old; 3. 6 minutes walking distance (6MWD) >=75 meters; 4. Stand up from the seat =50%; 6. Systemic glucocorticoid therapy for >=6 months, and the dose is fixed for at least 3 months; 7. History of the past 6 months recorded disease is progressing; 8. Good compliance; 9. Patients can communicate verbally or nonverbally; 10. Voluntarily follow and guarantee the completion of the study process; 11. Informed consent forms must be signed.

Exclusion criteria

Exclusion criteria: 1. Consolidate a clear mental illness; 2. Combined with other neurodegenerative diseases or serious systemic diseases (such as heart failure, arrhythmia, renal dysfunction, retinal disease, hypotension, uncontrolled high blood pressure, etc.); 3. Combine tumors or other diseases that may reduce survival expectations; 4. Hormone (first treatment for dystrophic large muscular dystrophy due to hormonal therapy, whether hormone use time should be indicated in the inclusion criteria), immunoglobulin, immunosuppressant, CYP3A4 inhibitor or other drug therapy affecting muscle function; 5. Participate in other clinical trials; 6. Two or more MMPI (Minnesota Multiple Personality Test) test risk; 7. Neuropsychological assessment suggests impaired psychological or cognitive interference; 8. Unable to adapt to MRI, EMG and muscle biopsy; 9. Patients cannot understand informed consent and research purposes; 10. Pregnant women, or women who may become pregnant during the study; non-pregnant women must pass the ß-HCG test negative 7 days before the start of treatment.

Design outcomes

Primary

Measure	Time frame
6-minute walking distance (6MWD);	—

Countries

China

Contacts

Public ContactYuncheng Wu

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

drwu2006@163.com+86 18930313198

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026