Status:
UNKNOWN
Mesenchymal Stem Cells Transplantation to Patients With Spinal Cord Injury
Lead Sponsor:
Guangzhou General Hospital of Guangzhou Military Command
Conditions:
Spinal Cord Injury
Eligibility:
All Genders
16-60 years
Phase:
PHASE1
PHASE2
Brief Summary
The study is a phase I/II trial designed to establish the safety and efficacy of intravenous combined with intrathecal administration of autologous bone marrow derived mesenchymal stem cells to patien...
Detailed Description
Spinal cord injury (SCI) is a traumatic disorder resulting in a functional deficit that usually leads to severe and permanent paralysis. Pharmacological and rehabilitation therapies to SCI get limited...
Eligibility Criteria
Inclusion
- Traumatic spinal cord injury at the thoracic or lumbar level.
- Age 16 to 60.
- American Spinal Injury Association Impairment Scale A or B.
- Time between injury and enrollment greater than 2 weeks and less than 1 year.
- Patients must have organ function as defined below:
- total bilirubin within normal institutional limits (NV: 0.0-20.5 umol/L); AST(SGOT)/ALT(SGPT) \<2.5 × institutional upper limit of normal AST (NV: 0-35 U/L); ALT (NV: 0-40 U/L) ; Creatinine within normal institutional limits (NV: 53-106 umol/L) or Creatinine clearance \>1.25 ml/s for patients with creatinine levels above institutional normal.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Patients may not be receiving any other investigational agents within 4 weeks of study entry.
- History of allergic reactions attributed to compounds of similar biologic composition to mesenchymal stem cells.
- Primary hematologic diseases.
- Open injuries.
- Psychiatric, addictive or any other disorder that compromises ability to give a truly informed consent.
- Malignancy within the last 5 years.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (defined as invasive fungal infection and progressive CMV viremia), symptomatic congestive heart failure (NYH class III and IV), unstable angina pectoris, or cardiac arrhythmia.
- Pregnant or breastfeeding women.
- HIV-positive patients.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01446640
Start Date
October 1 2011
End Date
June 1 2014
Last Update
October 5 2011
Active Locations (1)
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1
Guangzhou General Hospital of Guangzhou Military Command
Guangzhou, Guangdong, China, 510010