Allogeneic Cord Blood Cells for Adults With Severe Acute Contusion Spinal Cord Injury
Condition: Spinal Cord Contusion
MeSH terms: Spinal Cord Injuries; Contusions
Study type: Interventional
Phase: Phase 1/Phase 2

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/B). 20 patients were included. Half of patients received cell
      therapy in addition to standard therapy, while the other half received standard therapy only.
    

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 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.
    

Intervention name(s): Human Allogeneic Umbilical Cord Blood Mononuclear Cells (hUCBMCs) systemic (i.v.) infusions
Intervention type(s): Biological
Intervention description(s): HUCBMCs samples were prepared for infusion in the specialized laboratory of Cord Blood Bank (CryoCenter Ltd) and transported to the clinic immediately within 2 hours in the Dry Shipper. All samples were chosen according to patients blood group and rhesus-factor.
All samples were examined for hemotransmissive infections and cell viability prior to the preparation.
Obtained samples were infused through the blood transfusion systems with additional filter after 3 tests for biological and individual compatibility and tolerance.
Each patient of the pilot group received 4 cell infusions (1 infusion per week) with 1 week interval during the in-hospital treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 20 patients having acute contusion spinal cord injury (3 days post-trauma max) and ASIA A/B neurological deficit were divided into 2 groups: pilot group (n = 10) receiving hUCBMC treatment in addition to standard therapy and control group (n = 10) receiving standard treatment.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: spinal cord injury; ASIA A/B; cell therapy; cord blood stem cells; regenerative medicine