Overview

Intrathecal Transplantation of UC-MSC in Patients With Sub-Acute 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 sub-acute 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 from 2 weeks to 2 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