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Clinical study on the safety and efficacy of human-derived oligodendrocyte precursor cells in the treatment of white matter injury in premature infants

Clinical study on the safety and efficacy of human-derived oligodendrocyte precursor cells in the treatment of white matter injury in premature infants

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100055023
Enrollment
Unknown
Registered
2021-12-30
Start date
2022-02-01
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

White matter injury of prematurity

Interventions

Group 1:OPC nasal drip transplantation
Group 2:OPC was injected into lumbar subarachnoid space and transplantation

Sponsors

The Sixth Medical Center of the Chinese People's Liberation Army General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 25 weeks <= gestational age < 32 weeks. 2. History or laboratory indicators suggest fetal intrauterine hypoxia or infection. 3. Clinical manifestations: poor response, altered consciousness (excessive excitement, irritability, drowsiness and coma), convulsions, abnormal muscle strength and muscle tone, repeated apnea, etc. 4. aEEG or EEG abnormalities. 5. Brain MRI and/or ultrasound showed abnormal white matter. 6. Informed consent of the legal guardian. 1, 5 and 6 are required conditions, 2 medical history and laboratory must meet at least 1 of these conditions, 3 and 4 must meet one of them.

Exclusion criteria

Exclusion criteria: 1. Uncorrectable serious internal environment disorder or life-threatening. 2. Obstructive hydrocephalus. 3. Systemic coagulation disorders. 4. Major congenital structural deformities, hereditary and metabolic diseases. 5. Intracranial infection, immune deficiency. 6. Patients who are considered by the researchers to be inappropriate to participate in this clinical study.

Design outcomes

Primary

MeasureTime frame
NBNA scale and total body exercise assessment;

Countries

China

Contacts

Public ContactLuan Zuo

The Sixth Medical Center of the Chinese People's Liberation Army General Hospital

luanzuo@aliyun.com+86 18600310270

Outcome results

None listed

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