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

Spinal Cord Injury Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01676441
• Other study ID #: Cerecellgram-spine
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: August 2008
• Est. completion date: March 4, 2021

Study information

• Verified date: March 2021
• Source: Pharmicell Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: March 4, 2021
• Est. primary completion date: March 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Drug:
• cellgram-spine
Mesenchymal stem cells transplantation

Locations

Country	Name	City	State
Korea, Republic of	Asan medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Pharmicell Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of adverse events	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
Primary	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.; 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	Baseline, post operation(24 hours), 1 month, 3 month, 6 month, 12 month
Secondary	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).	Baseline, post operation(24 hours), 1 month, 3 month, 6 month, 12 month
Secondary	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).	6 months
Secondary	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.	6 months