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

C

Chinese Academy of Sciences

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Spinal Cord Injury

Treatments

Procedure: Surgical intradural decompression and adhesiolysis
Biological: NeuroRegen Scaffold with BMMCs transplantation

Study type

Interventional

Funder types

Other

Identifiers

NCT02688062
CAS-XDA-SDSCI/IGDB

Details and patient eligibility

About

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.

Enrollment

22 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

22 participants in 2 patient groups

NeuroRegen Scaffold with BMMCs transplantation
Experimental group
Treatment:
Biological: NeuroRegen Scaffold with BMMCs transplantation
Surgical intradural decompression and adhesiolysis
Experimental group
Treatment:
Procedure: Surgical intradural decompression and adhesiolysis

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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