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

Biological/cell based

General health

Online since 8 November 2021, updated 1139 days ago

About this trial

This is a phase 2 trial to test the safety and use of umbilical cord stem cells (allogeneic umbilical cord derived mesenchymal stem cells: UC-MSC) in a “late stage” of chronic spinal cord injury (>12 months post-injury). If included, the participant will receive an intrathecal injection of either 1) UC-MSC or 2) placebo (no UC-MSC), into the CSF (cerebrospinal fluid) around the spinal cord, once a month for 4 months. The participant will be followed for 12 months.

Included participants

Gender

All

Age

18 - 65 years

Injury level

C1 - S5

Severity (AIS)?

AIS-A

AIS-B

AIS-C

AIS-D

Time since injury

12 months - 65 years

Injury type

Traumatic

Healthy volunteers

C1-S5

Additionally, participants must

have a traumatic spinal cord injury for at least 12 months.

have one of the following ASIA impairment scale (AIS):

AIS A: complete; no feeling or movement below the injury,

What’s involved

Type

Biological/cell based

Details

If included, the participant will receive an intrathecal injection of either 1) UC-MSC or 2) placebo (no UC-MSC), into the CSF (cerebrospinal fluid) around the spinal cord, once a month for 4 months. The participant will be followed for 12 months.

Potential benefits

Main benefits

General health

Additional benefits

Arm/hand function

Bladder health/function

Sensory function

Standing/walking/mobility

Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

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