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

This study is currently recruiting participants.
Verified August 2012 by Pharmicell Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Pharmicell Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01676441
First received: August 23, 2012
Last updated: August 28, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention Phase
Spinal Cord Injury
 Procedure: Mesenchymal stem cell transplantation
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pharmicell Co., Ltd.:

Primary Outcome Measures:
  • Motor Score of the American Spinal Injury Association (ASIA) scale [ Time Frame: 12months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sensory score of the American Spinal Injury Association (ASIA) scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Electromyogram and Electroneurophysiologic test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Motor Evoked Potentials, Somatosensory Evoked Potentials

  • MRI and Diffusion Tensor Imaging of spinal cord [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 32
Study Start Date: August 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01676441

Contacts
Contact: Sangryong Jeon, MD, PhD 82-2-3010-3562 srjeon@amc.seoul.kr
Contact: Junghee Shin 82-2-3010-6503 yunbe@hanmail.net

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

Publications:

Responsible Party: Pharmicell Co., Ltd.
ClinicalTrials.gov Identifier: NCT01676441     History of Changes
Other Study ID Numbers: Cerecellgram-spine
Study First Received: August 23, 2012
Last Updated: August 28, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

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

ClinicalTrials.gov processed this record on May 22, 2013