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

N

Naval Military Medical University (Second Military Medical University)

Status and phase

Enrolling
Phase 2

Conditions

Spinal Cord Injury

Treatments

Drug: Placebo
Biological: Autologous bone marrow-derived mononuclear cells

Study type

Interventional

Funder types

Other

Identifiers

NCT04528550
202082201

Details and patient eligibility

About

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.

Enrollment

45 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

45 participants in 2 patient groups, including a placebo group

Autologous bone marrow-derived mononuclear cells
Experimental group
Description:
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.
Treatment:
Biological: Autologous bone marrow-derived mononuclear cells
Control
Placebo Comparator group
Description:
Included patients will receive the same amount of saline through lumbar injection.
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Central trial contact

Bangke Zhang, M.D.; Xuhua Lu, M.D.

Data sourced from clinicaltrials.gov

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