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

• Status: Terminated
• Trial end date: 2021-03-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmicell Co., Ltd.

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