Autologous Bone Marrow-derived Mononuclear Cells for Acute Spinal Cord Injury

NCT04528550 | Unknown Phase 2 DMC

• 1 other identifier: 202082201
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of intrathecal transplantation of autologous bone marrow-derived mononuclear cells for the treatment of traumatic acute spinal cord injury. Spinal cord injury can be divided into three phases, which are acute (within 2 weeks), sub-acute (2 weeks to 6 months), and chronic (over 6 months). Early treatment is the key to improve the prognosis, however, the majority of clinic trails nowadays are focusing on sub-acute or chronic phase because it takes 4-6 weeks to expand the autologous stem cells. In this study, the investigators will treat patients with acute spinal cord injury with autologous bone marrow-derived mononuclear cells and compare with the control group.

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• American Spinal Injury Association (ASIA) Impairment Scale

  Change in sensory and motor function as measured by the American Spinal Injury Association (ASIA) Impairment Scale. The ASIA Impairment Scale describes a person's functional impairment (both motor and sensory) as a result of their spinal cord injury. The scale has 5 levels, ranging from A (complete) to E (normal).

  baseline, 1 month, 3 months, 6 months and 12 months post-treatment

Secondary Outcomes (3)

• Incidence of adverse events

  1 month post-treatment

• Motor Evoked Potentials (MEP) and Somatosensory Evoked Potentials (SSEP) test

  baseline, 3 months, 6 months and 12 months post-treatment

• Residual urine test

  baseline, 3 months, 6 months and 12 months post-treatment

Study Arms (2)

Autologous bone marrow-derived mononuclear cells

EXPERIMENTAL

Intrathecal transplantation of autologous bone marrow-derived mononuclear cells through lumbar injection in acute phase. Each included patient will receive a single dose of 100 million autologous bone marrow-derived mononuclear cells.

Biological: Autologous bone marrow-derived mononuclear cells

Control

PLACEBO COMPARATOR

Included patients will receive the same amount of saline through lumbar injection.

Drug: Placebo

Interventions

Autologous bone marrow-derived mononuclear cells BIOLOGICAL

Intrathecal transplantation of autologous bone marrow-derived mononuclear cells through lumbar injection.

Autologous bone marrow-derived mononuclear cells

Placebo DRUG

Included patients will receive the same amount of saline through lumbar injection.

Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged between 18 and 60 years
• Traumatic spinal cord injury
• ASIA Impairment Scale A-D
• The injury must be within two weeks
• Patients submitted written informed consent

You may not qualify if:

• Traumatic spinal cord injury with brain injury or peripheral nerve injury
• Patients with severe multiple injuries and unstable vital signs
• Non-traumatic spinal cord injury caused by spinal tumors, hematoma, myelitis, etc.
• Patients with central spinal cord injury
• Patients with a completely transected spinal cord
• Patients with fever or acute infection
• Ongoing infectious disease, such as tuberculosis, HIV, hepatitis, syphilis, etc.
• Patients with anemia, coagulopathy, and other known blood system diseases
• Patients with malignant tumour
• Patients with neurodegenerative diseases, or any neuropathies
• Patients with ankylosing spondylitis
• Patients with a previous history of spinal surgery
• Patients who are pregnant or possibly pregnant
• Patients with psychiatric, addictive or any other mental disorders that can not give a truly informed consent
• Patients who are participating in other clinical trials

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, 200003, China

RECRUITING

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 Officials

• Xuhua Lu

  Shanghai Changzheng Hospotal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuhua Lu, M.D.

CONTACT

86-21-81885793; xuhualu@hotmail.com

Bangke Zhang, M.D.

CONTACT

8618301783716; zbk12345@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Traumatic Orthopaedic Department

Model Details: A 2:1 ratio of randomization (intervention group: control group) was used.

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 27, 2020
• Study Start: October 1, 2020
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 7, 2021

Record last verified: 2021-07

Locations

CN (1)