Allogeneic Cord Blood Cells for Adults With Severe Acute Contusion Spinal Cord Injury

NCT ID: NCT04331405

Last Updated: 2020-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-18
• Study Completion Date: 2018-09-05

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/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.

Conditions

Spinal Cord Contusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pilot 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.

Group Type: EXPERIMENTAL

Human Allogeneic Umbilical Cord Blood Mononuclear Cells (hUCBMCs) systemic (i.v.) infusions

Intervention Type: BIOLOGICAL

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.

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 standard therapy during in-hospital treatment. After the discharge patients were examined for 4 times. Observation period was 1 year.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Human Allogeneic Umbilical Cord Blood Mononuclear Cells (hUCBMCs) systemic (i.v.) infusions

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.

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

OTHER_GOV

Sponsor Role: collaborator

Sklifosovsky Institute of Emergency Care

OTHER_GOV

Sponsor Role: lead

Responsible Party

Vladimir A. Smirnov

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

N.V. Sklifosovsky Emergency Care Institute

Moscow, , Russia

Countries

Russia

Other Identifiers

41-18/03/2013

Identifier Type: -

Identifier Source: org_study_id