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

Spinal Cord Injury Clinical Trial

Official title:

NeuroRegen Scaffold™ With Bone Marrow Mononuclear Cells Transplantation vs. Intradural Decompression and Adhesiolysis in Patients With Chronic Spinal Cord Injury

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02688062
• Other study ID #: CAS-XDA-SDSCI/IGDB
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• Start date: January 2016
• Est. completion date: December 2021

Study information

• Verified date: February 2016
• Source: Chinese Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 22
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

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.

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.

Locations

Country	Name	City	State
China	First Affiliated Hospital of PLA General Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Chinese Academy of Sciences	First Hospitals affiliated to the China PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvements in ASIA (American Spinal Injury Association) Impairment Scale		24 months
Primary	Improvements in Somatosensory Evoked Potentials (SSEP)		24 months
Primary	Improvements in Motor Evoked Potentials (MEP)		24 months
Secondary	Improvements in Independence Measures	Functional Independence Measure (FIM) will be assessed before and after surgery.	1, 3, 6, 12, 18 and 24 months
Secondary	Magnetic Resonance Imaging (MRI)	The change of treated spinal cord injury will be assessed by Magnetic Resonance Imaging (MRI) before and after surgery.	1, 3, 6, 12, 18 and 24 months
Secondary	Improvements in Urinary and Bowel Function	The ability to feel and control urination and bowel will be assessed based on bladder pressure monitory before and after surgery.	1, 3, 6, 12, 18 and 24 months
Secondary	Safety and Tolerability assessed by Adverse Events	Proportion of patients with postoperative infections and serious adverse events (SAEs) will be assessed by long term follow-up.	Up to 6 months