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

NCT02688062 | Unknown Phase 1

• 1 other identifier: CAS-XDA-SDSCI/IGDB
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (3)

• Improvements in ASIA (American Spinal Injury Association) Impairment Scale

  24 months

• Improvements in Somatosensory Evoked Potentials (SSEP)

  24 months

• Improvements in Motor Evoked Potentials (MEP)

  24 months

Secondary Outcomes (4)

• Improvements in Independence Measures

  1, 3, 6, 12, 18 and 24 months

• Magnetic Resonance Imaging (MRI)

  1, 3, 6, 12, 18 and 24 months

• Improvements in Urinary and Bowel Function

  1, 3, 6, 12, 18 and 24 months

• Safety and Tolerability assessed by Adverse Events

  Up to 6 months

Study Arms (2)

NeuroRegen Scaffold with BMMCs transplantation

EXPERIMENTAL

Biological: NeuroRegen Scaffold with BMMCs transplantation

Surgical intradural decompression and adhesiolysis

EXPERIMENTAL

Procedure: Surgical intradural decompression and adhesiolysis

Interventions

NeuroRegen Scaffold with BMMCs transplantation BIOLOGICAL

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.

NeuroRegen Scaffold with BMMCs transplantation

Surgical intradural decompression and adhesiolysis PROCEDURE

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.

Surgical intradural decompression and adhesiolysis

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Completely spinal cord injury at the thoracic level as assessed by magnetic resonance imaging (MRI) and electrophysiology.
• ASIA Impairment Scale (AIS) grade A.
• Male or female, 18-60 years old.
• No significant further improvement after injury and rehabilitation.
• Patients with normal peripheral nerve function and without muscle atrophy.
• Cardiovascular, respiratory, liver, kidney functions and laboratory examinations are within normal ranges.
• No brain disease or mental disorder.
• Ability and willingness to regular visit to hospital and follow up during the protocol procedures.
• Patients signed informed consent.

You may not qualify if:

• 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).
• Patients without any rehabilitation train after injury.
• Remarkable muscle atrophy or fibrosis.
• Degeneration of peripheral nerve function.
• Allergic constitution.
• Participation in any immunomodulator therapy or experimental drug treatment within 60 days prior to study.
• Suffering diabetes, autoimmune diseases, tumor or severe hypertension.
• Patients with severe heart, lung, liver or renal dysfunction are unable to meet the surgery standards.
• Severe bleeding tendency or abnormal coagulation function.
• Inflammation or skin ulcers at the surgical site.
• Lactating and pregnant woman.
• Poor compliance, difficult to complete the study.
• Any other conditions that might increase the risk of subjects or interfere with the clinical trial.

Sponsors & Collaborators

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

Study Sites (1)

First Affiliated Hospital of PLA General Hospital

Beijing, 100101, China

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jianwu Dai, Ph.D.

  Chinese Academy of Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS

Study Record Dates

• First Submitted: February 6, 2016
• First Posted: February 23, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 23, 2020

Record last verified: 2016-02

Locations

CN (1)