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

NCT01676441 | Terminated Phase 2

• 1 other identifier: Cerecellgram-spine
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

spinal cord injury; mesenchymal stem cell

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (3)

• Sensory score of the American Spinal Injury Association (ASIA) scale

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

• Electrophysiological change (Motor Evoked Potentials-MEP, Somatosensory Evoked Potentials-SSEP)

  6 months

• MRI and Diffusion Tensor Imaging of spinal cord

  6 months

Other Outcomes (1)

• Number of adverse events

  Baseline to 12 months

Study Arms (1)

cellgram-spine

EXPERIMENTAL

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

Interventions

cellgram-spine DRUG

Mesenchymal stem cells transplantation

Also known as: Mesenchymal stem cells

cellgram-spine

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 16-65 years
• Traumatic spinal cord injury at the level of cervical
• American Spinal Injury Association Impairment Scale B
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharmicell Co., Ltd.: lead

Study Sites (1)

Asan medical center

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 22127044 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Sangryong Jeon, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 23, 2012
• First Posted: August 31, 2012
• Study Start: August 1, 2008
• Primary Completion: March 4, 2021
• Study Completion: March 4, 2021
• Last Updated: March 23, 2021

Record last verified: 2021-03

Locations

KR (1)