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

NCT04331405 | Completed Phase 1

• 1 other identifier: 41-18/03/2013
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Contusion

Keywords

spinal cord injury; ASIA A/B; cell therapy; cord blood stem cells; regenerative medicine

Outcome Measures

Primary Outcomes (3)

• Incidence of Treatment-Emergent Adverse Events [Safety]

  All potential adverse events were analyzed during the first year after SCI. All adverse events (AEs) were classified using CTCAE v5.0 classification system in each of 10 patients of pilot group. Severity of AEs: Grade 1 - mild; asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2 - moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL; Grade 3 - severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; Grade 4 - life-threatening consequences; urgent intervention indicated; Grade 5 - death related to AE. Relationship to the investigated therapy method: Degree 1 - unrelated; Degree 2 - possibly related; Degree 3 - probably related; Degree 4 - definitely related.

  1 year

• Neurological Deficit Change [ASIA scale]

  Dynamics of neurological deficit level within 1 year after SCI was analyzed using ASIA clinical scale: ASIA A - total motor and sensory impairment; ASIA B - total motor impairment and partial sensory impairment below SCI level or pelvic sensitivity preserved; ASIA C - incomplete motor (at least half of key muscle strength less than 3 points) and sensory impairment; ASIA D - incomplete motor (at least half of key muscle strength more than 3 points) and sensory impairment; ASIA E - normal. Neurological deficit level was compared between pilot and control groups.

  Change from Baseline at 1 year after SCI

• Quality of Life [FIM scale]

  Quality of life level was assessed within 1 year after SCI using FIM (functional impairment) scale. FIM scale evaluates 5 groups of parameters including motor functions and self-service, mobility, motion level, pelvic functions and intellectual functions (e.g. communication and social activity). Each group includes several parameters assessed using point system (maximum 7 points for each parameter). A total sum of points is counted and compared between pilot and control groups.

  1 year after SCI

Secondary Outcomes (6)

• Motor Deficit Change [Muscle Strength]

  Change from Baseline at 1 year after SCI

• Independent Verticalization Ability

  1 year after SCI

• Lower Extremities Spasticity Level [Modified Asworth scale]

  1 year after SCI

• Feeling of Bladder Filling

  1 year after SCI

• Urinary Inconsistence

  1 year after SCI

Study Arms (2)

Pilot group

EXPERIMENTAL

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.

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

Control group

NO INTERVENTION

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.

Interventions

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

Pilot group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sklifosovsky Institute of Emergency Care: lead
• National Medical Research Center for Cardiology, Ministry of Health of Russian Federation: collaborator

Study Sites (1)

N.V. Sklifosovsky Emergency Care Institute

Moscow, 129090, Russia

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: 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.

Study Record Dates

• First Submitted: March 29, 2020
• First Posted: April 2, 2020
• Study Start: March 18, 2013
• Primary Completion: March 21, 2018
• Study Completion: September 5, 2018
• Last Updated: April 2, 2020

Record last verified: 2020-03

Locations

RU (1)