ARC-IM Therapy To Support and Promote Recovery of Ambulatory Functions in People With Subacute and Chronic Spinal Cord Injury

Who can take part

• Must be at least 18 years old and no older than 65 years old at the time of enrollment
• Must be graded A, B, C, or D in the ASIA Impairment Scale (AIS)
• Must have a SCI level at T10 or higher as determined by ISNCSCI, with the region extending 6 cm above the tip of the conus remaining anatomically intact as determined by MRI
• Must have sustained their injury either less than 6 weeks prior to baseline (Group "Subacute SCI"), or more than 1 year prior to enrollment (Group "Chronic SCI")
• Must be suffering from a SCI due to trauma
• Must have a stable medical, physical and psychological condition as considered by the investigators and the delegated specialists
• Must have residual upper limb function to use the arms for weight bearing support (as determined by functional demonstration)
• Must be able to understand and interact with the study team in German, French or English
• Must agree to comply in good faith with all conditions of the study and to attend all scheduled appointments
• Must provide Informed Consent as documented by signature prior to any study-related procedures
• Must have an acceptable or highly effective method of contraception for women of childbearing capacity

Who cannot take part

• Must not have participated in another clinical study using drugs or medical devices within the 30 days preceding and during the present study
• Must not have previously been injected with stem cells in the spinal cord
• Must not have a history of epilepsy
• Must not have any diseases and conditions that would increase the morbidity and mortality of SCI surgery
• Must not have any existing contraindication to mobility functions (e.g., unhealed bone fractures, central nervous system disorder, peripheral nerve disorder, etc.)
• Must not suffer from SCI from other etiology than trauma (ischemic, tumoral, autoimmune, etc.)
• Must not have any other conditions that would make the subject unable to participate in testing in the judgment of the investigators (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
• Must not be pregnant nor breastfeeding
• Must not have brain damage
• Must not require ventilator support
• Must not have any anatomical limitations in the implantation area as judged by the investigators (e.g., spinal stenosis, limiting protrusions, post-traumatic bone damage at area of implantation)
• Must not require the use of an intrathecal baclofen pump
• Must not have any active implanted devices
• Must not be the investigator him/herself, his/her family members, employees or other dependent persons