AzTrials
AzTrials

Spinal Cord InjuryPhase 2/3NCT01676441

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

A Phase 2/3 study testing cellgram-spine in people with Spinal Cord Injury, run by Pharmicell Co., Ltd. at 1 site in South Korea.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 16 to 65 years
Conditions the study is for
Spinal Cord Injury
What is being tested?
cellgram-spine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSouth Korea
Study dates
Aug 2008to 4 Mar 2021
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Asan medical center

    Seoul

Other trials in South Korea

About this study

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.

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.

Read the 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.

Being tested
cellgram-spine
Keywords
spinal cord injury, mesenchymal stem cell
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cellgram-spineDrug

    Also called Mesenchymal stem cells

    Mesenchymal stem cells transplantation

Study groups in NCT01676441
Study groupRoleWhat they receive
cellgram-spineExperimentalposterior 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
Receives: Drug: cellgram-spine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    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

    Measured: Baseline, post operation(24 hours), 1 month, 3 month, 6 month, 12 month

Secondary outcomes (3)

  1. 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".

    Measured: Baseline, post operation(24 hours), 1 month, 3 month, 6 month, 12 month

  2. 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).

    Measured: 6 months

  3. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2012 (estimated)
  2. Study startAug 2008
  3. Primary completion4 Mar 2021
  4. Study completion4 Mar 2021

Why it stopped: sponsor decision (confidential)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01676441
Sponsor's protocol ID
Cerecellgram-spine
Status last verified
Mar 2021
First submitted
23 Aug 2012
Last updated
23 Mar 2021
Results posted
No
Data monitoring committee
No

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.

    PubMed 22127044

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing cellgram-spine in people with Spinal Cord Injury, run by Pharmicell Co., Ltd. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: sponsor decision (confidential)). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01676441, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in