Safety and Efficacy of Autologous Mesenchymal Stem Cells in Chronic Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01676441
Recruitment Status : Active, not recruiting
First Posted : August 31, 2012
Last Update Posted : October 7, 2016
Information provided by (Responsible Party):
Pharmicell Co., Ltd.

Brief Summary:
This phase II/III clinical trial is designed to evaluate the safety and efficacy of autologous Mesenchymal Stem Cells (MSC) transplanted directly into the injured spinal cord.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Procedure: Mesenchymal stem cell transplantation Phase 2 Phase 3

Detailed Description:
The Principal investigator has performed a clinical trial using autologous MSCs in patients with cervical spinal cord injury. The results revealed the safety of autologous MSC. This Phase II, III single-center trial is to assess the safety and efficacy of bone marrow-derived mesenchymal stem cell transplantation direct to injured spinal cord site via laminectomy. After recovery from the operation, the subjects receive 4 weeks of physical and occupational therapy.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II/III Clinical Trial to Evaluate the Safety and Efficacy of Bone Marrow-derived Mesenchymal Stem Cell Transplantation in Patients With Chronic Spinal Cord Injury.
Study Start Date : August 2008
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Mesenchymal stem cell
Procedure: posterior cervical laminectomy and MSC transplantation. After laminectomy, 1.6X107 and 3.2 X107 Autologous MSCs is injected into the intramedullary and intrathecal space respectively
Procedure: Mesenchymal stem cell transplantation
Other Name: cerecellgram-spine

Primary Outcome Measures :
  1. Motor Score of the American Spinal Injury Association (ASIA) scale [ Time Frame: 12months ]

Secondary Outcome Measures :
  1. Sensory score of the American Spinal Injury Association (ASIA) scale [ Time Frame: 12 months ]
  2. Electromyogram and Electroneurophysiologic test [ Time Frame: 6 months ]
    Motor Evoked Potentials, Somatosensory Evoked Potentials

  3. MRI and Diffusion Tensor Imaging of spinal cord [ Time Frame: 6 months ]
  4. Number of adverse events [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Aged between 16-65 years
  • Traumatic spinal cord injury at the level of cervical
  • American Spinal Injury Association Impairment Scale B
  • 12 months or more post spinal cord injury subject with stable neurological finding after more than 1 month rehabilitation therapy
  • No signs of contracture
  • Good physical condition to go through operation
  • Must be willing and able to participate in study procedures with no mental and verbal problem
  • Able to consent by patients or legal representatives

Exclusion Criteria:

  • Serum SGOT/SGPT > 3 X upper limit of normal or Creatinine > 1.5 X upper limit of normal
  • Major surgical procedure in the past 3 months
  • Penetrating injury
  • Mechanical ventilation
  • Serious pre-existing medical conditions
  • Recently diagnosed infection (Urinary tract infection, Pneumonia etc)
  • Positive skin test for penicillin
  • Positive result for viral markers (human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) and Venereal Disease Research Laboratory (VDRL) test)
  • Pregnant women, women of childbearing potential who do not want adequate contraception, breastfeeding females
  • Unwilling to participate in study
  • Patients with psychiatric disorder severe as to make compliance with the treatment unlike, and signing informed consent impossible
  • Drug abuse in the past 1 year
  • Participating in other clinical trials in the past 1 month
  • Inappropriate patients to participate in the study according to the chief investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01676441

Korea, Republic of
Asan medical center
Songpagu, Seoul, Korea, Republic of
Sponsors and Collaborators
Pharmicell Co., Ltd.
Principal Investigator: Sangryong Jeon, MD, PhD Asan Medical Center

Responsible Party: Pharmicell Co., Ltd. Identifier: NCT01676441     History of Changes
Other Study ID Numbers: Cerecellgram-spine
First Posted: August 31, 2012    Key Record Dates
Last Update Posted: October 7, 2016
Last Verified: October 2016

Keywords provided by Pharmicell Co., Ltd.:
spinal cord injury
mesenchymal stem cell

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System