Clinical study on the safety and efficacy of umbilical cord blood mononuclear cells in the treatment of Duchenne muscular dystrophy

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400094101

Enrollment

Unknown

Registered

2024-12-17

Start date

2024-12-31

Completion date

Unknown

Last updated

2025-01-06

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

Conditions

Duchenne muscular dystrophy

Interventions

Control:The control group was treated with normal saline for the first three times and CB-MNCs for the last three times Each dose of CB-MNCs preparation contained 3 × 10 ^ 8 cord blood derived mononuc

Experimental:CB-MNCs were applied for 6 times in the experimental group Each dose of CB-MNCs preparation contained 3 × 10 ^ 8 cord blood derived mononuclear cells

Eligibility

Sex/Gender

All

Age

7 Years to 16 Years

Inclusion criteria

Inclusion criteria: (1) Male children diagnosed with DMD (2) Ages between 7 and 16 (3) Participants were able to walk independently with a 6-minute walking distance of 250-400 meters (4) Participants were able to cooperate with exercise assessment test, cardiac magnetic resonance examination, and blood related examination (5) and received standard treatment (such as glucocorticoids) stably for at least 6 months (6) Able to undergo muscle biopsy under anesthesia without biopsy contraindications (7) Parents or legal guardians agree to participate and can sign the informed consent form

Exclusion criteria

Exclusion criteria: (1) Have severe heart disease, liver or kidney dysfunction (2) Allergic reactions to known components of mononuclear cells (3) HIV+TPPA+, patients diagnosed with HBV or HCV (4) Tumor markers+ (5) Severe psychosis, cognitive dysfunction (6) Coagulation dysfunction (7) Uncontrolled hypertension after treatment, blood pressure = 180mmhg/110mmhg (8) Other severe systemic or organic diseases (9) Participated in other trials in the past 3 months (10) Received any stem cell therapy in the past 6 months (11) Other criteria deemed unsuitable by the investigator for inclusion

Design outcomes

Primary

Measure	Time frame
Improvement in lower limb function;6-minute walking distance;	—

Secondary

Measure	Time frame
Supine standing time;10-meter walk time;Improvement in upper limb function;Cardiac magnetic resonance;echocardiogram;pulmonary function test;	—

Countries

China

Contacts

Public ContactShiwen Wu

Chinese PLA General Hospital

wu_shiwen@outlook.com+86 10 5549 9136

Outcome results

None listed

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