Stem Cells in Spinal Cord Injury

Launched by NEUROPLAST · May 1, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the use of stem cells to help people who have experienced spinal cord injuries. The goal is to see if injecting stem cells can improve recovery and function in patients who have suffered from a traumatic spinal cord injury, specifically those with complete or incomplete injuries that affect the spinal cord between the neck (C4) and the middle of the back (T12). This study is for adults aged 18 to 65 who are within 6 to 10 weeks of their injury.

To participate, individuals must meet certain criteria, such as having a specific type of spinal cord injury and not having other serious health issues like certain infections or cancers. Participants will receive either the stem cell treatment or a placebo (a treatment that looks the same but has no active ingredients) to compare the effects. They will be monitored closely throughout the trial to assess their health and any changes in their condition. This study aims to provide valuable information about the potential benefits of stem cell therapy for spinal cord injury recovery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age range: 18 - 65 years
• • Complete (AIS grade A) or incomplete (AIS grade B or C) TSCI (ISNCSCI-assessed) at time of randomization
• • Randomization can be done within 6-10 weeks after the TSCI incident
• • Level of injury between C4 to T12
• • Voluntary signed informed consent by patients and Investigator before any trial-related procedures are performed
• Exclusion Criteria:
• • SCI AIS grade D or E at the start of enrolment
• • Level of SCI above C4 or below T12
• • Positive HIV, hepatitis B or C serology
• • Positive Lues test
• • Total Nuclear Cell (TNC) count \< 1x109 TNC
• • Cancer, brain injury, disturbed consciousness, signs/symptoms of neurodegenerative disorder (e.g. stroke, amyotrophic lateral sclerosis, multiple sclerosis etc), diabetes mellitus type 1, renal or cardiac insufficiency based on anamnesis history and at the investigator's discretion
• • Patients suffering from respiratory issues that cannot breathe on their own 24/7
• • Any concomitant treatment or medication that interferes with the conduct of the trial, such as immune-suppressive medication or other medication (especially methotrexate, cyclosporine, and corticosteroids have to be avoided) known to interact with the anti- inflammatory and immune-modulative actions of stem cells (non-steroid anti- inflammatory drugs (NSAIDs) are allowed)
• • Abuse of alcohol (daily consumption of more than 2 units of alcohol containing drinks) or illicit drugs (e.g. heroin, cocaine, XTC)
• • Individuals that belong to vulnerable population groups
• • Females with childbearing potential without using adequate birth control methods, and/or being pregnant or in the lactation period
• • Participation in any clinical trial (with exemption of descriptive studies with questionnaires and no active intervention) within the previous 30 days before enrolment, or simultaneous participation in such trial
• • Patients with extreme comorbidity before or after the TSCI are excluded at discretion of the PI
• • Patients who are unable to comply with the requirements of this clinical trial