Allogeneic Cord Blood Cells for Adults With Severe Acute Contusion Spinal Cord Injury
Spinal Cord Contusion
About this trial
This is an interventional treatment trial for Spinal Cord Contusion focused on measuring spinal cord injury, ASIA A/B, cell therapy, cord blood stem cells, regenerative medicine
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- N.V. Sklifosovsky Emergency Care Institute
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Pilot group
Control group
10 patients with acute severe contusion spinal cord injury (ASIA A/B) included into the group. Patients meeting inclusion/exclusion criteria underwent primary surgical treatment (decompression and stabilization) received hUCBMC infusions weekly (4 infusions overall) in addition to standard therapy during in-hospital treatment. After the discharge patients were examined for 4 times. Observation period was 1 year.
10 patients with acute severe contusion spinal cord injury (ASIA A/B) included into the group. Patients meeting inclusion/exclusion criteria underwent primary surgical treatment (decompression and stabilization) received standard therapy during in-hospital treatment. After the discharge patients were examined for 4 times. Observation period was 1 year.