What side effects are associated with this type of intervention?

Common treatments for spinal cord injury, including experimental therapies like NVG-291, often involve the use of neurotrophic factors, stem cell therapies, and other neuroprotective agents. Known side effects of these treatments can include mild to moderate adverse events such as chills, fatigue, fever, headache, and nausea. More serious but less common side effects may include infusion reactions, cerebrovascular events, and transient ischemic attacks. Additionally, treatments involving high doses of neurotrophic factors or stem cells may carry risks of immune reactions and potential tumor formation. It is important for patients to discuss these potential risks with their healthcare provider to make informed decisions about their treatment options.

What prior FDA approvals exist?

The FDA has approved several treatments aimed at managing spinal cord injury, though many focus on symptom management rather than direct neuroregeneration. Methylprednisolone, a corticosteroid, was previously used for its anti-inflammatory properties to reduce secondary damage post-injury, though its use has become controversial. More recently, research has focused on neuroprotective and regenerative therapies, such as stem cell treatments and neurotrophic factors, though these are still largely in experimental stages. NVG-291, which is being studied for its potential to promote neuroregeneration and functional recovery, represents a novel approach in this ongoing effort to find effective treatments for SCI.

What other types of research exist?

Promising novel alternatives to NVG-291 for spinal cord injury treatment in 2024 include: 1) Stem cell therapies, such as those using mesenchymal stem cells (MSCs) or induced pluripotent stem cells (iPSCs), which have shown potential in promoting neural repair and functional recovery. 2) Neuroprotective agents like riluzole, which may help in reducing secondary damage post-injury. 3) Regenerative medicine approaches, including the use of biomaterials and scaffolds to support tissue regeneration and repair. These therapies are in various stages of clinical trials and have shown encouraging results in preclinical and early clinical studies.

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NVG-291 for Spinal Cord Injury

Phase 1 & 2

Recruiting

Research Sponsored by NervGen Pharma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Summary

This trial is testing a new drug called NVG-291 to see if it can help people with spinal cord injuries. The study focuses on those with injuries that haven't fully healed. NVG-291 aims to improve nerve communication in the spinal cord, potentially leading to better movement and sensation.

Who is the study for?

This trial is for adults aged 18-75 with incomplete cervical spinal cord injury from physical trauma, able to take at least one step and have some hand grasp ability. They must be fluent in English, willing to follow the study plan, and not involved in another clinical trial or have certain medical conditions like severe pain, high BMI, or recent substance abuse.

What is being tested?

The study tests NVG-291 on people with spinal cord injuries. It's a randomized (people are put into groups by chance), double-blind (neither participants nor researchers know who gets what treatment), placebo-controlled (compared against an inactive substance) trial at Shirley Ryan AbilityLab.

What are the potential side effects?

Potential side effects of NVG-291 aren't specified here but generally could include reactions where the drug is administered, flu-like symptoms, headaches, or other unforeseen issues as it's under investigation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Electrophysiological

Secondary study objectives

10mWT time

9-HPT time

Graded and Redefined Assessment of Strength, Sensibility, and Prehension Test

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NVG-291 for InjectionExperimental Treatment1 Intervention

Injected under the skin (subcutaneous).

Group II: PlaceboPlacebo Group1 Intervention

Injected under the skin (subcutaneous).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

NVG-291

2021

Completed Phase 1

~80

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Spinal Cord Injury (SCI) focus on neuroprotection, axon regeneration, and neuronal reconnections. Neuroprotective interventions aim to minimize secondary damage post-injury by reducing inflammation and cell death. Treatments targeting axon regeneration and neuronal reconnections work to restore communication pathways within the spinal cord, potentially improving motor and sensory functions. These mechanisms are crucial for SCI patients as they address the multifaceted nature of SCI, aiming to maximize functional recovery. The NVG-291 trial likely explores similar therapeutic effects, emphasizing the importance of these approaches in enhancing patient outcomes.

Emerging molecular therapeutic targets for spinal cord injury.Hyperbaric oxygen therapy of spinal cord injury.