search
Back to results

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

Primary Purpose

Spinal Cord Injury

Status
Terminated
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
cellgram-spine
Sponsored by
Pharmicell Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring spinal cord injury, mesenchymal stem cell

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asan medical center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

cellgram-spine

Arm Description

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

Outcomes

Primary Outcome Measures

Compared change of Motor Score of the American Spinal Injury Association (ASIA) scale
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

Secondary Outcome Measures

Sensory score of the American Spinal Injury Association (ASIA) scale
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)
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
Post 6 months of cell treatment, the ratio of patients with changes in magnetic resonance imaging is analyzed.

Full Information

First Posted
August 23, 2012
Last Updated
March 21, 2021
Sponsor
Pharmicell Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT01676441
Brief Title
Safety and Efficacy of Autologous Mesenchymal Stem Cells in Chronic Spinal Cord Injury
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 Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
sponsor decision (confidential)
Study Start Date
August 2008 (undefined)
Primary Completion Date
March 4, 2021 (Actual)
Study Completion Date
March 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmicell Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
spinal cord injury, mesenchymal stem cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cellgram-spine
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
cellgram-spine
Other Intervention Name(s)
Mesenchymal stem cells
Intervention Description
Mesenchymal stem cells transplantation
Primary Outcome Measure Information:
Title
Compared change of Motor Score of the American Spinal Injury Association (ASIA) scale
Description
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
Time Frame
Baseline, post operation(24 hours), 1 month, 3 month, 6 month, 12 month
Secondary Outcome Measure Information:
Title
Sensory score of the American Spinal Injury Association (ASIA) scale
Description
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".
Time Frame
Baseline, post operation(24 hours), 1 month, 3 month, 6 month, 12 month
Title
Electrophysiological change (Motor Evoked Potentials-MEP, Somatosensory Evoked Potentials-SSEP)
Description
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).
Time Frame
6 months
Title
MRI and Diffusion Tensor Imaging of spinal cord
Description
Post 6 months of cell treatment, the ratio of patients with changes in magnetic resonance imaging is analyzed.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Number of adverse events
Description
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.
Time Frame
Baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sangryong Jeon, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan medical center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
22127044
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs