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

NCT ID: NCT01676441

Last Updated: 2021-03-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2021-03-04

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.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

cellgram-spine

Intervention Type: DRUG

Mesenchymal stem cells transplantation

Interventions

cellgram-spine

Mesenchymal stem cells transplantation

Intervention Type: DRUG

Other Intervention Names

Mesenchymal stem cells

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pharmicell Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sangryong Jeon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan medical center

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: BACKGROUND

PMID: 22127044 (View on PubMed)

Other Identifiers

Cerecellgram-spine

Identifier Type: -

Identifier Source: org_study_id