Safety and Efficacy of Autologous Mesenchymal Stem Cells in Chronic Spinal Cord Injury

Biological/cell based

General health

Online since 10 July 2024, updated 199 days ago

About this trial

This clinical trial is recruiting individuals with chronic incomplete cervical (neck area) spinal cord injuires to test the safety and effectiveness of transplanted stem cells (autologous mesenchymal stem cells). The stem cells are harvested and processed from each participant’s bone marrow, limiting any immune rejection response. Participants will undergo spinal surgery to expose the spinal cord, followed by the injection of the stem cells into the spinal cord and surrounding spinal fluid. After surgery, participants will receive 4 weeks of physical and occupational training. This study will investigate changes in motor and sensory function.

Included participants

Gender

All

Age

16 - 65 years

Injury level

C1 - C8

Severity (AIS)?

AIS-B

Time since injury

≥ 12 months

Injury type

Traumatic

Healthy volunteers

C1-C8

Additionally, participants must

NOT have undergone major surgery in past 3 months

NOT be dependent on mechanical ventilator

NOT have penetrating injury, e.g. gunshot or stab wound

What’s involved

Type

Biological/cell based

Details

The total duration of this study is approximately one year and involves the following: Undergo a procedure to harvest bone marrow cells Spinal surgery to inject the bone marrow-derived stem cells into the spinal cord and surrounding spinal fluid 4 weeks of physical and occupational therapy Assessment of outcome measures 24 hours, 1 month, 3 months, 6 months and 12 months after surgery

Potential benefits

Main benefits

General health

Additional benefits

Arm/hand 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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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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