NeuroRegen Scaffold™ With Bone Marrow Mononuclear Cells Transplantation vs. Intradural Decompression and Adhesiolysis in SCI
NCT ID: NCT02688062
Last Updated: 2020-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
22 participants
INTERVENTIONAL
2016-01-31
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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NeuroRegen Scaffold with BMMCs transplantation
NeuroRegen Scaffold with BMMCs transplantation
Patients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with bone marrow mononuclear cells (BMMCs) transplantation after localized scars cleared and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures.
Surgical intradural decompression and adhesiolysis
Surgical intradural decompression and adhesiolysis
Patients with chronic SCI (ASIA grade A) will receive intradural decompression and adhesiolysis surgery and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures.
Interventions
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NeuroRegen Scaffold with BMMCs transplantation
Patients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with bone marrow mononuclear cells (BMMCs) transplantation after localized scars cleared and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures.
Surgical intradural decompression and adhesiolysis
Patients with chronic SCI (ASIA grade A) will receive intradural decompression and adhesiolysis surgery and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures.
Eligibility Criteria
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Inclusion Criteria
2. ASIA Impairment Scale (AIS) grade A.
3. Male or female, 18-60 years old.
4. No significant further improvement after injury and rehabilitation.
5. Patients with normal peripheral nerve function and without muscle atrophy.
6. Cardiovascular, respiratory, liver, kidney functions and laboratory examinations are within normal ranges.
7. No brain disease or mental disorder.
8. Ability and willingness to regular visit to hospital and follow up during the protocol procedures.
9. Patients signed informed consent.
Exclusion Criteria
2. Patients without any rehabilitation train after injury.
3. Remarkable muscle atrophy or fibrosis.
4. Degeneration of peripheral nerve function.
5. Allergic constitution.
6. Participation in any immunomodulator therapy or experimental drug treatment within 60 days prior to study.
7. Suffering diabetes, autoimmune diseases, tumor or severe hypertension.
8. Patients with severe heart, lung, liver or renal dysfunction are unable to meet the surgery standards.
9. Severe bleeding tendency or abnormal coagulation function.
10. Inflammation or skin ulcers at the surgical site.
11. Lactating and pregnant woman.
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.
18 Years
60 Years
ALL
No
Sponsors
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First Hospitals affiliated to the China PLA General Hospital
OTHER_GOV
Chinese Academy of Sciences
OTHER_GOV
Responsible Party
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Jianwu Dai
Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS
Principal Investigators
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Jianwu Dai, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Sciences
Locations
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First Affiliated Hospital of PLA General Hospital
Beijing, , China
Countries
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Other Identifiers
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CAS-XDA-SDSCI/IGDB
Identifier Type: -
Identifier Source: org_study_id