NeuroRegen Scaffold™ With Stem Cells for Chronic Spinal Cord Injury Repair

Chinese Academy of Sciences

Status and phase: Unknown; Phase 1

Conditions: Spinal Cord Injury

Treatments: Biological: NeuroRegen scaffold with BMMCs or MSCs transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT02352077

CAS-XDA-SCI/IGDB

Details and patient eligibility

About

The purpose of this study is to assess the safety and efficacy of NeuroRegen scaffold with bone marrow mononuclear cells (BMMCs) or mesenchymal stem cells (MSCs) in patients with chronic spinal cord injury.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female, 18-65 years old.
2. Completely spinal cord injury at the cervical and thoracic level (C5-T12).
3. Classification ASIA A with no significant further improvement.
4. Patients signed informed consent.
5. Ability and willingness to regular visit to hospital and follow up during the protocol Procedures.

Exclusion criteria

1. A current diagnosis of any primary diseases affecting limb functions (e.g., trauma, infection, tumors, congenital malformations, peripheral muscular dystrophy, Huntington's disease, Parkinson's disease).
2. Serious complications (e.g., hydronephrosis due to renal insufficiency, severe bedsores (Ⅲ° above), lower extremity venous thrombosis, severe myositis ossificans).
3. History of life threatening allergic or immune-mediated reaction.
4. Clinically significant abnormalities in routine laboratory examinations (hematology, electrolytes, biochemistry, liver and kidney function tests, urinanalysis).
5. History of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders.
6. Severe arrhythmias (e.g., ventricular tachycardia, frequent superventricular tachycardia, atrial fibrillation, and atrial flutter) or cardiac degree II or above conduction abnormalities displayed via 12-lead ECG.
7. Lactating and pregnant woman.
8. Alcohol drug abuse /dependence.
9. Participated in any other clinical trials within 3 months before the enrollment.
10. A drug or treatment known to cause effect on the central nervous system during the past four weeks.
11. A drug or treatment known to cause major organ system toxicity during the past four weeks.
12. Poor compliance, difficult to complete the study.
13. Any other conditions that might increase the risk of subjects or interfere with the clinical trial.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

NeuroRegen Scaffold with BMMCs or MSCs transplantation

Experimental group

Treatment:

Biological: NeuroRegen scaffold with BMMCs or MSCs transplantation