Title

NeuroRegen Scaffold™ With Stem Cells for Chronic Spinal Cord Injury Repair
Safety and Efficacy of NeuroRegen Scaffold™ With Bone Marrow Mononuclear Cells or Mesenchymal Stem Cells for Chronic Spinal Cord Injury Repair
  • Phase

    Phase 1
  • Study Type

    Interventional
  • Status

    Unknown status
  • Study Participants

    30
The purpose of this study is to assess the safety and efficacy of NeuroRegen scaffold with bone marrow mononuclear cells (BMMCs) or mesenchymal stem cells (MSCs) in patients with chronic spinal cord injury.
Study Started
Jan 31
2015
Primary Completion
Dec 31
2021
Anticipated
Study Completion
Dec 31
2021
Anticipated
Last Update
Dec 23
2020

Biological NeuroRegen scaffold with BMMCs or MSCs transplantation

Patients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with bone marrow mononuclear cells (BMMCs) or mesenchymal stem cells (MSCs) transplantation after localized scars cleared and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures.

NeuroRegen Scaffold with BMMCs or MSCs transplantation Experimental

Criteria

Inclusion Criteria:

Male or female, 18-65 years old.
Completely spinal cord injury at the cervical and thoracic level (C5-T12).
Classification ASIA A with no significant further improvement.
Patients signed informed consent.
Ability and willingness to regular visit to hospital and follow up during the protocol Procedures.

Exclusion Criteria:

A current diagnosis of any primary diseases affecting limb functions (e.g., trauma, infection, tumors, congenital malformations, peripheral muscular dystrophy, Huntington's disease, Parkinson's disease).
Serious complications (e.g., hydronephrosis due to renal insufficiency, severe bedsores (Ⅲ° above), lower extremity venous thrombosis, severe myositis ossificans).
History of life threatening allergic or immune-mediated reaction.
Clinically significant abnormalities in routine laboratory examinations (hematology, electrolytes, biochemistry, liver and kidney function tests, urinanalysis).
History of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders.
Severe arrhythmias (e.g., ventricular tachycardia, frequent superventricular tachycardia, atrial fibrillation, and atrial flutter) or cardiac degree II or above conduction abnormalities displayed via 12-lead ECG.
Lactating and pregnant woman.
Alcohol drug abuse /dependence.
Participated in any other clinical trials within 3 months before the enrollment.
A drug or treatment known to cause effect on the central nervous system during the past four weeks.
A drug or treatment known to cause major organ system toxicity during the past four weeks.
Poor compliance, difficult to complete the study.
Any other conditions that might increase the risk of subjects or interfere with the clinical trial.
No Results Posted