NeuroRegen Scaffold™ Combined With Stem Cells for Chronic Spinal Cord Injury Repair

Biological/cell based

Arm/hand function

Online since 2 November 2021, updated 897 days ago

About this trial

This is a trial recruiting individuals with chronic complete spinal cord injuries to test the effect of an implanted scaffold combined with stem cells into the injured spinal area. If selected, participants will be randomly assigned to receive either mesenchymal (usually derived from bone marrow, fat, or muscle*) or neural stem cells with the scaffold implant. The scaffold (NeuroRegen™) is a man-made structure intended to mimic the natural tissue environment to support stem cell growth. After surgery, all participants will receive rehabilitation, psychological and nutritional interventions. Outcome assessments will be performed over a 24 month period after surgery. *Note: detailed information about the stem cells, source of cells, need for immune suppression, etc. is not available on clinicaltrials.gov and will need to be provided by the investigator.

Included participants

Gender

All

Age

18 - 65 years

Injury level

C5 - T12

Severity (AIS)?

AIS-A

Time since injury

≥ 0 hours

Injury type

Traumatic

Healthy volunteers

C5-T12

Additionally, participants must

have a chronic spinal cord injury

have a neurological level of injury between C5 and Th12

have the following ASIA impairment scale (AIS) classifications:

What’s involved

Type

Biological/cell based

Details

Surgery for excision of spinal cord scar and the implantation of the NeuroRegen Scaffold combined with either mesenchymal stem cells or combined with neural stem cells Rehabilitation, psychological and nutritional interventions after surgery Outcome assessments throughout the study duration of 24 months

Potential benefits

Main benefits

Arm/hand function

Additional benefits

Bladder health/function

Bowel health

General health

Mental health and psychosocial factors

Sensory function

Standing/walking/mobility

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

Wings for Life supports SCITrialsFinder

Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

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