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

Biological/cell based

General health

Online since 2 November 2021, updated 914 days ago

About this trial

This trial is recruiting individuals with complete chronic spinal cord injuries to test the safety and effect of implanting a scaffold structure loaded with bone marrow cells or bone marrow-derived stem cells. The scaffold (NeuroRegen) provides a suitable growth environment for the cells. Participants will undergo spinal surgery for the implantation of the scaffold and cells into the spinal cord. Researchers will assess the safety of the procedure and measure whether it promotes neurological recovery. Note: This study is enrolling by invitation only.

Included participants

Gender

All

Age

18 - 65 years

Injury level

C5 - T12

Severity (AIS)?

AIS-A

Time since injury

≥ 1 month

Injury type

Traumatic

Healthy volunteers

C5-T12

Additionally, participants must

be able and willing to make regular visits to the hospital for follow-up assessments.

NOT have contraindications for MRI scanning, e.g. metal in body

What’s involved

Type

Biological/cell based

Details

The total duration of the study is 12 months and will involve the following participant activities: Undergo spinal surgery for transplantation of the scaffold and cells into the injured spinal cord. Undergo comprehensive rehabilitation, psychological, and nutritional intervention after surgery. Participate in outcome assessments 6 months and 12 months after the surgery.

Potential benefits

Main benefits

General health

Additional benefits

Arm/hand function

Bladder health/function

Bowel health

Mental health and psychosocial factors

Pain

Sensory function

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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