Endothelial Function Treatment for Spinal Cord Injury

Overseen By Andrew Park, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Craig Hospital

Disqualifiers: Hypertension, Cardiovascular disease, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 week

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand why individuals with spinal cord injuries face a higher risk of heart attacks and strokes at a younger age. Researchers will examine the health of endothelial cells, which line blood vessels and influence heart health, to determine if these cells sustain damage after a spinal cord injury. The trial seeks to aid in developing treatments to prevent future heart problems. Ideal participants are those who have experienced a spinal cord injury for over a year, resulting in paraplegia, and have no history of heart disease or related health issues. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new preventive treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that treatments using drugs affecting blood flow and protecting cells have been tested before. These studies have focused on their effects on blood vessels, particularly for individuals with spinal cord injuries.

These drugs generally aim to improve blood flow and reduce damage from harmful molecules in the body. Although detailed safety information is limited, early studies typically assess how well people tolerate these treatments by checking for side effects and how the body processes the drugs.

Since specific safety data isn't available from these sources, it is crucial to understand that early studies prioritize ensuring the treatment's safety for participants. Prospective trial participants should inquire about any known side effects or how past participants have reacted to gain a clearer understanding of what to expect. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to explore the role of endothelial function in cardiovascular disease (CVD) risk specifically for individuals with spinal cord injury (SCI). Unlike traditional CVD risk assessments, which often overlook the unique physiological changes caused by SCI, this trial focuses on understanding how these changes impact heart health. By comparing individuals with and without SCI, researchers hope to uncover insights that could lead to tailored preventive strategies or therapies for this population, potentially improving their cardiovascular outcomes.

What evidence suggests that this trial's treatments could be effective for improving vessel health in individuals with spinal cord injury?

This trial will examine the effects of brachial intra-arterial infusion of vasoactive and antioxidant drugs on endothelial cells in individuals with spinal cord injuries. Research has shown that endothelial cells, which line blood vessels, play a crucial role in heart health. Damage to these cells can increase the risk of heart attacks and strokes, particularly in those with spinal cord injuries. Studies have found that certain drugs, which regulate blood flow and act as antioxidants, can maintain blood vessel health. These drugs reduce oxidative stress, which harms cells, and improve blood flow. This treatment aims to repair endothelial cell issues in people with spinal cord injuries, potentially reducing their risk of heart disease. ^{1 6 7 8 9}

Who Is on the Research Team?

Andrew Park, MD

Principal Investigator

Craig Hospital

Are You a Good Fit for This Trial?

Inclusion Criteria

My spinal cord injury was caused by a traumatic event.

It has been over a year since my injury.

I have complete paralysis from the chest down.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline measurements of endothelial function and microvesicle concentration are taken

1 week

1 visit (in-person)

Treatment

Pharmacological manipulation with acetylcholine and sodium nitroprusside to assess vasodilation

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Brachial intra-arterial infusion of vasoactive and antioxidant drugs
• venous phlebotomy

How Is the Trial Designed?

Group I: Spinal Cord Injury Experimental Treatment 6 Interventions

Men and women of all races, ethnic backgrounds, over the age of 18 years: adults with chronic (\>12 months), motor complete (AIS A/B) SCI with paraplegia (neurological level of injury \[NLI\] at T2 or below).

Group II: Control (Non-Spinal Cord Injury) Experimental Treatment 6 Interventions

Non-injured men and women of all races, ethnic backgrounds, over the age of 18 years.

Who Is Running the Clinical Trial?

Craig Hospital

Lead Sponsor

Trials

45

Recruited

8,400+

University of Colorado, Boulder

Collaborator

Trials

128

Recruited

29,600+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39137515/

Evaluation of Oral Vasoactive Medications to Maintain ... Department of Surgery, West Virginia University School of Medicine, Morgantown, West Virginia. PMID: 39137515; DOI: 10.1016/j.jss.2024.07.059 ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2772529425000621

Current and emergent therapies targeting spinal cord injury Magnesium Sulfate Treatment in Experimental Spinal Cord Injury: Emphasis on Vascular Changes and Early Clinical Results ... Spinal cord injury sequelae alter drug ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9698573/

Promising Advances in Pharmacotherapy for Patients with ... ... Spinal Cord Injury—A Review of Studies Performed In Vivo with Modern Drugs ... In recent SCI studies, the drug has demonstrated antioxidant, anti ...

4. researchgate.net researchgate.net/publication/387443898_Advancements_in_Antioxidant-Based_Therapeutics_for_Spinal_Cord_Injury_A_Critical_Review_of_Strategies_and_Combination_Approaches

A Critical Review of Strategies and Combination Approaches ... Drug Delivery Issues. Despite the promising efficacy of antioxidant therapies, demonstrated in preclinical. studies, several challenges remain ...

5. mdpi.com mdpi.com/2076-3921/14/9/1081

A Review of the Potential Use of Antioxidants in Spinal ... These nanoparticles had an average particle size of approximately 130 nm and achieved a drug loading efficiency of 21.39 ± 2.53% [323]. ... Drug for Spinal Cord ...

6. nature.com nature.com/articles/sc2012136

Peripheral vascular function in spinal cord injury Physical Medicine and Rehabilitation: State of the Art Reviews. ... Oxidative stress in spinal cord injury and antioxidant-based intervention.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12447234/

Early Blood Pressure Targets in Acute Spinal Cord Injury To compare the efficacy and safety of augmented vs conventional blood pressure on 6-month neurologic outcomes after acute spinal cord injury.

8. mdpi.com mdpi.com/2077-0383/14/3/902

Vasopressor Use in Acute Spinal Cord Injury Drugs and Drug Candidates (DDC), Dynamics, Earth, Ecologies, Econometrics ... Failure of Mean Arterial Pressure Goals to Improve Outcomes Following Penetrating ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT04295538

NCT04295538 | Safety And Efficacy Study Of Intravenous ... American Spinal Injury Association Impairment Scale (AIS) grade A or B at Screening. Able to initiate study drug administration within 24 hours of injury.