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

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ClinicalTrials.gov Identifier: NCT02688062
Recruitment Status : Recruiting
First Posted : February 23, 2016
Last Update Posted : January 3, 2018
Sponsor:
Collaborator:
First Hospitals affiliated to the China PLA General Hospital
Information provided by (Responsible Party):
Jianwu Dai, Chinese Academy of Sciences

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 Type : Interventional  (Clinical Trial)
Estimated 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 : January 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Improvements in ASIA (American Spinal Injury Association) Impairment Scale [ Time Frame: 24 months ]
  2. Improvements in Somatosensory Evoked Potentials (SSEP) [ Time Frame: 24 months ]
  3. Improvements in Motor Evoked Potentials (MEP) [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Improvements in Independence Measures [ Time Frame: 1, 3, 6, 12, 18 and 24 months ]
    Functional Independence Measure (FIM) will be assessed before and after surgery.

  2. Magnetic Resonance Imaging (MRI) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 6 months ]
    Proportion of patients with postoperative infections and serious adverse events (SAEs) will be assessed by long term follow-up.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02688062


Contacts
Contact: Zhifeng Xiao, Ph.D. 86-10-82614420 zfxiao@genetics.ac.cn
Contact: Sufang Han, Ph.D. 86-10-82614420 sufanghan22@genetics.ac.cn

Locations
China
First Affiliated Hospital of PLA General Hospital Recruiting
Beijing, China, 100101
Contact: Jiaguang Tang, M.D.    86-10-66848872    tangjiaguang2013@163.com   
Contact: Xiaoxiong Yang    86-10-66848873    yangxiaoxiong1166@163.com   
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

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     History of Changes
Other Study ID Numbers: CAS-XDA-SDSCI/IGDB
First Posted: February 23, 2016    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: February 2016

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries