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Trial record 10 of 56 for:    stem cell Spinal Cord Injury AND cells

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.

Tracking Information
First Submitted Date  ICMJE August 23, 2012
First Posted Date  ICMJE August 31, 2012
Last Update Posted Date March 22, 2019
Study Start Date  ICMJE August 2008
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: August 28, 2012)
Motor Score of the American Spinal Injury Association (ASIA) scale [ Time Frame: 12months ]
Change History Complete list of historical versions of study NCT01676441 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
  • 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".
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2012)
  • Sensory score of the American Spinal Injury Association (ASIA) scale [ Time Frame: 12 months ]
  • Electromyogram and Electroneurophysiologic test [ Time Frame: 6 months ]
    Motor Evoked Potentials, Somatosensory Evoked Potentials
  • MRI and Diffusion Tensor Imaging of spinal cord [ Time Frame: 6 months ]
  • Number of adverse events [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures
 (submitted: March 20, 2019)
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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Autologous Mesenchymal Stem Cells in Chronic Spinal Cord Injury
Official Title  ICMJE 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.
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE 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
Condition  ICMJE Spinal Cord Injury
Intervention  ICMJE Drug: cellgram-spine
Mesenchymal stem cells transplantation
Other Name: Mesenchymal stem cells
Study Arms  ICMJE 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
Intervention: Drug: cellgram-spine
Publications * Park JH, Kim DY, Sung IY, Choi GH, Jeon MH, Kim KK, Jeon SR. Long-term results of spinal cord injury therapy using mesenchymal stem cells derived from bone marrow in humans. Neurosurgery. 2012 May;70(5):1238-47; discussion 1247. doi: 10.1227/NEU.0b013e31824387f9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 28, 2012)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: JIYEOUN JEONG 82-2-3496-0134 jyjeong@pharmicell.com
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01676441
Other Study ID Numbers  ICMJE Cerecellgram-spine
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pharmicell Co., Ltd.
Study Sponsor  ICMJE Pharmicell Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sangryong Jeon, MD, PhD Asan Medical Center
PRS Account Pharmicell Co., Ltd.
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP