Intrathecal Transplantation of UC-MSC in Patients With Late Stage of Chronic Spinal Cord Injury

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study aim to evaluate the safety and efficacy of intrathecal transplantation of allogeneic umbilical cord derived mesenchymal stem cells (UC-MSC) for treatment of different phrases of spinal cord injury. Here, the history of spinal cord injury is divided into three periods, Sub-acute SCI, Early stage of chronic SCI, and Late stage of chronic SCI, which is 2W-2M, 2M-12M, and more than 12M after injury, respectively. The purpose is to investigate whether the patients with spinal cord injury benefit from UC-MSC transplantation, and then find out the best time for SCI treatment.

In this part of the study, the investigators will treat patients with late stage of chronic spinal cord injury with UC-MSC transplantation or placebo.

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

Details

• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
• Collaborators: Shanghai East Hospital; West China Hospital

Criteria

Inclusion Criteria:

• Age 18 to 65

• Traumatic spinal cord injury

• ASIA Impairment Scale A-D

• Participants who understand and sign inform consent

• Duration of injury more than 12 months

Exclusion Criteria:

• Traumatic spinal cord injury with brain injury

• Non-traumatic spinal cord injury caused by spinal tumors, myelitis, demyelination, spinal vascular malformation, etc.

• with Ankylosing spondylitis

• with Malignant tumors

• with Neurodegenerative diseases, or any neuropathies

• with Hematologic diseases, or blood coagulation disorder

• with Hepatic dysfunction, renal dysfunction

• Ongoing or active infectious diseases

• Pregnancy, or lactation women

• Psychiatric, addictive or any other disorder that compromises ability to give a truly informed consent

• Not agree to take part in clinical trial or can't finish follow up

• Previous history of MSCs therapy

• Participation in another clinical trial