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

Pharmicell

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Spinal Cord Injury

Treatments: Drug: cellgram-spine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01676441

Cerecellgram-spine

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

cellgram-spine

Experimental group

Description:

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

Treatment:

Drug: cellgram-spine