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

• Sponsor: Chinese Academy of Sciences (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02688062
• Collaborator: First Hospitals affiliated to the China PLA General Hospital (Other)
• Enrollment: 22
• Location: 1
• Arms: 2
• Duration (Months): 71
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injury	Biological: NeuroRegen Scaffold with BMMCs transplantation; Procedure: Surgical intradural decompression and adhesiolysis	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: NeuroRegen Scaffold™ With Bone Marrow Mononuclear Cells Transplantation vs. Intradural Decompression and Adhesiolysis in Patients With Chronic Spinal Cord Injury
• Study Start Date: Jan 1, 2016
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NeuroRegen Scaffold with BMMCs transplantation	Biological: 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.
Experimental: Surgical intradural decompression and adhesiolysis	Procedure: 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.

Outcome Measures

Primary Outcome Measures

1. Improvements in ASIA (American Spinal Injury Association) Impairment Scale [24 months]

2. Improvements in Somatosensory Evoked Potentials (SSEP) [24 months]

3. Improvements in Motor Evoked Potentials (MEP) [24 months]

Secondary Outcome Measures

1. Improvements in Independence Measures [1, 3, 6, 12, 18 and 24 months]

   Functional Independence Measure (FIM) will be assessed before and after surgery.

2. Magnetic Resonance Imaging (MRI) [1, 3, 6, 12, 18 and 24 months]

   The change of treated spinal cord injury will be assessed by Magnetic Resonance Imaging (MRI) before and after surgery.

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

   The ability to feel and control urination and bowel will be assessed based on bladder pressure monitory before and after surgery.

4. Safety and Tolerability assessed by Adverse Events [Up to 6 months]

   Proportion of patients with postoperative infections and serious adverse events (SAEs) will be assessed by long term follow-up.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Affiliated Hospital of PLA General Hospital	Beijing		China	100101

Sponsors and Collaborators

• Chinese Academy of Sciences
• First Hospitals affiliated to the China PLA General Hospital

Investigators

• Principal Investigator: Jianwu Dai, Ph.D., Chinese Academy of Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jianwu Dai, Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS, Chinese Academy of Sciences
• ClinicalTrials.gov Identifier: NCT02688062
• Other Study ID Numbers: CAS-XDA-SDSCI/IGDB
• First Posted: Feb 23, 2016
• Last Update Posted: Dec 23, 2020
• Last Verified: Feb 1, 2016

• Additional relevant MeSH terms: Spinal Cord Injuries

Study Results

No Results Posted as of Dec 23, 2020