Status:
COMPLETED
Allogeneic Cord Blood Cells for Adults With Severe Acute Contusion Spinal Cord Injury
Lead Sponsor:
Sklifosovsky Institute of Emergency Care
Collaborating Sponsors:
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Conditions:
Spinal Cord Contusion
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
Study evaluates the safety and primary efficiency of systemic (i.v.) allogeneic human umbilical cord blood mononuclear cell infusions in patients with severe acute contusion spinal cord injury (ASIA A...
Detailed Description
Present study was prospective randomized open-label clinical study, Phases I/IIa. Randomization was performed using envelope method (50 envelopes including Cell Therapy and Standard Therapy, 25 of eac...
Eligibility Criteria
Inclusion
- acute spinal cord injury (first 3 days after trauma)
- contusion type of SCI (MRI-confirmed)
- Russian citizenship
- Informed consent understood and signed by the patient
Exclusion
- systolic arterial pressure (APsyst) \> 185 mmHg OR diastolic AP (APdia) \> 105 mmHg OR indications for aggressive AP lowering using i.v. therapy
- myocardial infarction within 3 months prior to SCI
- glucose level \< 3.5 mM/L or \> 21 mM/L
- organic CNS pathology
- acute internal organs diseases requiring surgical treatment
- autoimmune diseases
- serious surgical treatment or severe trauma within 3 months prior to SCI
- pregnancy or breast feeding
- acute infections including tuberculosis, syphilis, HIV, hepatitis B and C etc.
- severe acute and chronic hematological diseases
- rare patient's blood group parameters preventing adequate hUCBMCs sample selection (e.g. Kell+, A2B group, rare phenotype etc.)
- any benign or oncological tumors (if not fully treated prior to SCI)
- inability to participate in key examination following clinic discharge
- any psychiatric diseases preventing patient from informed consent OR treatment plan understanding
- confirmed hypersensitivity and/or allergy to any component of the studied biological compound
- inability to accomplish present study protocol
Key Trial Info
Start Date :
March 18 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04331405
Start Date
March 18 2013
End Date
September 5 2018
Last Update
April 2 2020
Active Locations (1)
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1
N.V. Sklifosovsky Emergency Care Institute
Moscow, Russia, 129090