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
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Drug: cellgram-spine||Phase 2 Phase 3|
|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)|
|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|
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
Mesenchymal stem cells transplantation
Other Name: Mesenchymal stem cells
- 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
- Palpable or visible contraction
- Active movement, full Range Of Motion(ROM) with gravity eliminated
- Active movement, full ROM against gravity
- Active movement, full ROM against gravity and moderate resistance in a muscle specific position
- (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
- 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.
- 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.
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
|Contact: JIYEOUN JEONGfirstname.lastname@example.org|
|Korea, Republic of|
|Asan medical center||Recruiting|
|Seoul, Korea, Republic of|
|Principal Investigator: Sangryong Jeon|
|Principal Investigator:||Sangryong Jeon, MD, PhD||Asan Medical Center|