NeuroRegen Scaffold™ With Bone Marrow Mononuclear Cells Transplantation vs. Intradural Decompression and Adhesiolysis in SCI

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02688062
• Date of registration: 06/02/2016
• Prospective Registration: No
• Primary sponsor: Chinese Academy of Sciences
• Public title: NeuroRegen Scaffold™ With Bone Marrow Mononuclear Cells Transplantation vs. Intradural Decompression and Adhesiolysis in SCI
• Scientific title: NeuroRegen Scaffold™ With Bone Marrow Mononuclear Cells Transplantation vs. Intradural Decompression and Adhesiolysis in Patients With Chronic Spinal Cord Injury
• Date of first enrolment: January 2016
• Target sample size: 22
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT02688062
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

China

Contacts

• Name: Jianwu Dai, Ph.D.
• Affiliation: Chinese Academy of Sciences

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Completely spinal cord injury at the thoracic level as assessed by magnetic resonance
imaging (MRI) and electrophysiology.

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:

1. A current diagnosis of any primary diseases affecting limb functions (e.g., traumatic
brain injury, cerebral hemorrhage, cognitive disorders or other central nervous system
diseases).

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.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Spinal Cord Injury

Intervention(s)

Biological: NeuroRegen Scaffold with BMMCs transplantation

Procedure: Surgical intradural decompression and adhesiolysis

Primary Outcome(s)

Improvements in ASIA (American Spinal Injury Association) Impairment Scale [Time Frame: 24 months]

Improvements in Motor Evoked Potentials (MEP) [Time Frame: 24 months]

Improvements in Somatosensory Evoked Potentials (SSEP) [Time Frame: 24 months]

Secondary Outcome(s)

Improvements in Urinary and Bowel Function [Time Frame: 1, 3, 6, 12, 18 and 24 months]

Improvements in Independence Measures [Time Frame: 1, 3, 6, 12, 18 and 24 months]

Magnetic Resonance Imaging (MRI) [Time Frame: 1, 3, 6, 12, 18 and 24 months]

Safety and Tolerability assessed by Adverse Events [Time Frame: Up to 6 months]

Secondary ID(s)

CAS-XDA-SDSCI/IGDB

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

First Hospitals affiliated to the China PLA General Hospital