Safety and Efficacy of SC0806 (Fibroblast Growth Factor 1 and a Device) in Traumatic Spinal Cord Injury Subjects

Biological/cell based

Standing/walking/mobility

Online since 2 November 2021, updated 688 days ago

About this trial

This trial is recruiting individuals with chronic complete thoracic (chest area) spinal cord injuries to test implantation of a biodegradable device containing nerve segments and growth molecules intended to boost nerve activity. The primary focus of the study is safety; motor improvements will also be measured by spinal cord motor nerve conduction. If included, participants will randomly undergo device implant surgery and walking training, or walking training only (control group). Follow-up will occur over 18 months. The control group will be offered surgical implantation of the device after completion of the study, if there are no major safety concerns.

Included participants

Gender

All

Age

18 - 65 years

Injury level

T2 - T11

Severity (AIS)?

AIS-A

Time since injury

4 months - 10 years

Injury type

Traumatic

Healthy volunteers

T2-T11

Additionally, participants must

have a BMI of less than 35.

have a body height of less than 195cm (<6’4 feet).

have a body weight of less than 125kg (<275 lbs).

What’s involved

Type

Biological/cell based

Details

For the trial the participant will be randomly assigned either to undergo surgery to implant the device into the spinal cord and participate in study-specific walking training or assigned to only participate in study-specific walking training. Follow-up will be done over the following 18 months.

Potential benefits

Main benefits

Standing/walking/mobility

Additional benefits

General health

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

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