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

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ClinicalTrials.gov Identifier: NCT01676441
Recruitment Status : Recruiting
First Posted : August 31, 2012
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
Pharmicell Co., Ltd.

Study Description
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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 Drug: cellgram-spine 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Intervention Model: Single Group Assignment
Intervention Model Description:

posterior cervical laminectomy and Mesenchymal stem cells(cellgram-spine) tranplantation.

After laminectomy, 1.6X107 and 3.2 X107 Autologous Mesenchymal stem cells is injected into the intramedullary and intrathecal space respectively
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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: cellgram-spine
posterior cervical laminectomy and Mesenchymal stem cells tranplantation. After laminectomy, 1.6X10^7 and 3.2 X10^7 Autologous Mesenchymal stem cells is injected into the intramedullary and intrathecal space respectively
 Drug: cellgram-spine
Mesenchymal stem cells transplantation
Other Name: Mesenchymal stem cells


Outcome Measures
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Primary Outcome Measures :
  1. Compared change of Motor Score of the American Spinal Injury Association (ASIA) scale [ Time Frame: Baseline, post operation(24 hours), 1 month, 3 month, 6 month, 12 month ]

    Compared Baseline and after 6, 12 months of cell treatment, ASIA motor test analyzes the proportion of patients with a motor grade of more than 2 devision, with a motor grade improving from 2 to 3 and a rise of 5 or more in total score.

    <American Spinal Injury Association (ASIA) scale> 0 Total paralysis

    1. Palpable or visible contraction
    2. Active movement, full Range Of Motion(ROM) with gravity eliminated
    3. Active movement, full ROM against gravity
    4. Active movement, full ROM against gravity and moderate resistance in a muscle specific position
    5. (normal) Active movement, full ROM against gravity and full resistance in a functional muscle position expected from an otherwise unimpaired person 5* (normal) Active movement, full ROM against gravity and sufficient resistance to be considered normal if identified inhibiting factors (i.e. pain, disuse) were not present NT Not testable


Secondary Outcome Measures :
  1. Sensory score of the American Spinal Injury Association (ASIA) scale [ Time Frame: Baseline, post operation(24 hours), 1 month, 3 month, 6 month, 12 month ]

    Analyze the difference between the pre and post of the ASIA sensory score by using the Study's pre-test (Wilcoxon's signed test).

    <American Spinal Injury Association (ASIA) scale> The exam is based on neurological responses, touch and pinprick sensations tested in each dermatome, and strength of the muscles that control key motions on both sides of the body. Sensation is graded on a scale of 0-2: 0 is no sensation, 1 is altered or decreased sensation, and 2 is full sensation. Each side of the body is graded independently. When an area is not available (e.g. because of an amputation or cast), it is recorded as "NT", "not testable".


  2. Electrophysiological change (Motor Evoked Potentials-MEP, Somatosensory Evoked Potentials-SSEP) [ Time Frame: 6 months ]
    Post 6 months of treatment, the validity is analyzed through patients who have expressed their responses to the electrophysiological test (Motor Evoked Potentials-MEP, Somatosensory Evoked Potentials-SSEP).

  3. MRI and Diffusion Tensor Imaging of spinal cord [ Time Frame: 6 months ]
    Post 6 months of cell treatment, the ratio of patients with changes in magnetic resonance imaging is analyzed.


Other Outcome Measures:
  1. Number of adverse events [ Time Frame: Baseline to 12 months ]
    Analyze the laboratory, vital sign, ECG, physical exam, medical exam, chest X-ray results from baseline to end of the study for investigate adverse reactions and view safety.


Eligibility Criteria
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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
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
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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 ClinicalTrials.gov identifier (NCT number): NCT01676441


Contacts
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Contact: JIYEOUN JEONG 82-2-3496-0134 jyjeong@pharmicell.com

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

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Responsible Party: Pharmicell Co., Ltd.
ClinicalTrials.gov Identifier: NCT01676441     History of Changes
Other Study ID Numbers: Cerecellgram-spine
First Posted: August 31, 2012    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: November 2018
Keywords provided by Pharmicell Co., Ltd.:
spinal cord injury
mesenchymal stem cell
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System