Spinal Cord Contusion Clinical Trial
Official title:
Allogeneic Mononuclear Umbilical Cord Blood Systemic Infusions for Adult Patients With Severe Acute Contusion Spinal Cord Injury: Phase I Safety Study and Phase IIa Primary Efficiency Study
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/B). 20 patients were included. Half of patients received cell therapy in addition to standard therapy, while the other half received standard therapy only.
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 each).
20 patients with severe scute contusion spinal cord injury (cervical, thoracic and lumbar
cone segments) were included into the study. Patients were divided into 2 groups: pilot group
(n = 10) obtaining standard conservative therapy and 4 i.v. infusions of Human Allogeneic
Umbilical Cord Blood Mononuclear Cells (hUCBMCs) (~ 300 M in 100 mL) and control group (n =
10) obtaining standard conservative therapy only. Cell Therapy was initiated in patients
within 3 days after SCI episode after primary surgical decompression and/or stabilization was
performed. Patients inclusion decision depended on meeting the inclusion/exclusion criteria
and informed consent signed.
hUCBMC samples were prepared in the specialized laboratory and transported to the hospital
immediately within 2 hours. Cells infusions were performed following 3 tests for biological
compatibility and potential intolerance for each patient.
All four infusion were performed during in-hospital treatment. Observational period reached 1
year after SCI. All included patients were examined daily during in-hospital treatment
following 4 times within observational period (1 year).
All adverse events and potential complications were analyzed within 1 year after SCI using
CTCAE v5.0 classification.
Outcome parameters were analyzed at the end of observation and examined using standard
statistical instruments.
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