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

March 21, 2021 updated by: Pharmicell Co., Ltd.

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Mesenchymal stem cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, post operation(24 hours), 1 month, 3 month, 6 month, 12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
Baseline, post operation(24 hours), 1 month, 3 month, 6 month, 12 month
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).
6 months
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.
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmicell Co., Ltd.

Investigators

  • Principal Investigator: Sangryong Jeon, MD, PhD, Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (ACTUAL)

March 4, 2021

Study Completion (ACTUAL)

March 4, 2021

Study Registration Dates

First Submitted

August 23, 2012

First Submitted That Met QC Criteria

August 28, 2012

First Posted (ESTIMATE)

August 31, 2012

Study Record Updates

Last Update Posted (ACTUAL)

March 23, 2021

Last Update Submitted That Met QC Criteria

March 21, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cerecellgram-spine

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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