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Cord Blood Cells in Patients With Acute SCI

NCT05693181 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-01-20

No results posted yet for this study

Summary

This is a prospective, single-blinded, single-center, randomized, comparative, interventional clinical study of systemic mononuclear multiple allogenic cord blood cells administration safety and efficiency in patients having acute severe contusion spinal cord injury (ASIA A/B), phase I/II

Conditions

  • Spinal Cord Injury, Acute

Interventions

BIOLOGICAL

Multiple systemic (i.v.) administration of allogenic non-related group- and rhesus-compatible mononuclear cord blood cells

Each HUCBCs sample contain 500 +/- 50 x 10\*6 allogenic non-related group- and rhesus-compatible mononuclear cord blood cells

OTHER

Control vehicle (sterile saline)

Sterile saline infusion in control patients

Sponsors & Collaborators

  • State-Financed Health Facility "Samara Regional Medical Center Dinasty"

    collaborator OTHER

  • K.L. Hetagurov North-Osetian State University

    collaborator UNKNOWN

  • Sklifosovsky Institute of Emergency Care

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-05
Primary Completion
2024-12-31
Completion
2025-08-30

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05693181 on ClinicalTrials.gov