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Clinical study of human umbilical cord mesenchymal stem cells for repairing spinal cord injury by local combined intrathecal transplantation

Clinical study of human umbilical cord mesenchymal stem cells for repairing spinal cord injury by local combined intrathecal transplantation

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061962
Enrollment
Unknown
Registered
2022-07-13
Start date
2022-07-14
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

spinal cord injury

Interventions

Experimental group:Basic treatment + symptomatic treatment + laminectomy + human umbilical cord mesenchymal cell transplantation
Control group :Basic treatment + symptomatic treatment + laminectomy + normal saline

Sponsors

Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
13 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age between 13-65 years old, gender is not limited, body mass index (BMI) between 19-25 kg/m2 (BMI = weight (kg)/height (m) square), including the boundary value; 2. Meet the diagnostic criteria for traumatic spinal cord injury; 3. Sensory or motor loss below the level of injury; 4. Have not received stem cell therapy in the last 6 months; 5. The subjects themselves or their family members can sign the informed consent form according to the research procedures and instructions.

Exclusion criteria

Exclusion criteria: 1. Only symptoms of nerve root injury; 2. Only symptoms of cauda equina injury; 3. The mean arterial pressure (MAP) is less than 60 mmHg; 4. Glasgow score less than 13 points; 5. Pregnant, lactating women or women planning to become pregnant; 6. Under the age of 13 or over the age of 65 years; 7. The patient and his/her family members refuse to sign the test consent form; 8. The patient has a history of medical diseases with potential risks: history of diabetes, history of severe cardiovascular disease, concurrent serious infection focus, history of gastrointestinal bleeding, etc.; 9. Serum HIV antibody positive, syphilis antibody positive; 10. Patients with severe mental illness and cognitive impairment; 11. Other serious systemic or organ diseases; 12. Participated in other clinical research in the past 3 months; 13. The investigator believes that there are patients who cannot be included in this study for other reasons.

Design outcomes

Primary

MeasureTime frame
ASIA Spinal cord injury Score;IANR Spinal Cord Injury Function Assessment Scale;Functional Independence Assessment (FIM) Scale;Spinal Cord Injury Walking Index (WISCI);Neuroelectrophysiological examination;Bladder function;Imaging and ultrasound examination;

Secondary

MeasureTime frame
Routine laboratory examination;

Countries

China

Contacts

Public ContactFeng Shiqing

Tianjin Medical University General Hospital

sqfeng@tmu.edu.cn+86 13920286292

Outcome results

None listed

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