Clinical trial NCT02688062: NeuroRegen Scaffold™ With Bone Marrow Mononuclear Cells Transplantation vs. Intradural Decompression and Adhesiolysis in SCI
Official title: NeuroRegen Scaffold™ With Bone Marrow Mononuclear Cells Transplantation vs. Intradural Decompression and Adhesiolysis in Patients With Chronic Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Spinal Cord Injury
Lead sponsor: Chinese Academy of Sciences
Sponsor class: OTHER_GOV
Collaborators: name: First Hospitals affiliated to the China PLA General Hospital
First posted: 2016-02-23
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy and safety of NeuroRegen Scaffold with bone marrow mononuclear cells (BMMCs) on neurological recovery following chronic and complete spinal cord injury, compared to the treatment of surgical intradural decompression and adhesiolysis only.


Eligibility 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.

Primary outcomes:
measure: Improvements in ASIA (American Spinal Injury Association) Impairment Scale
timeFrame: 24 months
measure: Improvements in Somatosensory Evoked Potentials (SSEP)
timeFrame: 24 months
measure: Improvements in Motor Evoked Potentials (MEP)
timeFrame: 24 months
Secondary outcomes:
measure: Improvements in Independence Measures
timeFrame: 1, 3, 6, 12, 18 and 24 months
measure: Magnetic Resonance Imaging (MRI)
timeFrame: 1, 3, 6, 12, 18 and 24 months
measure: Improvements in Urinary and Bowel Function
timeFrame: 1, 3, 6, 12, 18 and 24 months
measure: Safety and Tolerability assessed by Adverse Events
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: First Affiliated Hospital of PLA General Hospital
Study officials:
affiliation: Chinese Academy of Sciences
name: Jianwu Dai, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: