What is the mechanism of action of this treatment?

Common treatments for stroke include neuroprotective and thrombolytic agents. Neuroprotective agents work by inhibiting pathways that lead to cell death, reducing inflammation, and maintaining cellular function, thereby protecting brain tissue from damage. Thrombolytic agents dissolve blood clots that obstruct blood flow to the brain, restoring circulation and minimizing brain damage. These treatments are crucial for stroke patients as they can significantly reduce brain injury, improve recovery outcomes, and decrease the likelihood of long-term disability.

What side effects are associated with this type of intervention?

Common treatments for acute ischemic stroke, such as thrombolytic agents like tissue plasminogen activator (tPA), can have side effects including bleeding complications, such as intracranial hemorrhage, and allergic reactions. Neuroprotective agents, which are still largely experimental, may have side effects that include nausea, vomiting, and potential neurotoxicity. The safety and tolerability of these treatments are critical considerations, as highlighted in studies like the NCS-01 trial.

What prior FDA approvals exist?

The FDA has approved several treatments for acute ischemic stroke, primarily focusing on thrombolytic agents. The most notable is tissue plasminogen activator (tPA), which is used to dissolve blood clots and improve blood flow to the brain. Administered within a few hours of stroke onset, tPA can significantly reduce the severity of stroke-related disabilities. Other treatments include mechanical thrombectomy devices, which physically remove clots from the brain's blood vessels. While neuroprotective agents are still under investigation, these thrombolytic therapies remain the cornerstone of acute ischemic stroke treatment.

What other types of research exist?

Promising alternatives to NCS-01 for stroke patients include Tenecteplase, a thrombolytic agent showing superior outcomes compared to alteplase in some studies, and NA-1 (nerinetide), a neuroprotective agent currently in Phase 3 trials demonstrating potential in reducing brain damage post-stroke. Both agents are under active investigation and may offer effective treatment options in 2024.

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NCS-01 for Stroke

Phase 1 & 2

Waitlist Available

Led By Sean Savitz, md

Research Sponsored by NC Medial Research Inc

Eligibility Criteria Checklist

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

Must have

Evidence of neurologic deficits as defined by NIHSS 6 to 18 or NIHSS < 6 with Fugl-Meyer upper extremity subtotal 6 to 40 inclusive

Clinical evidence of acute ischemic unilateral cerebral infarction

Must not have

Any malignancies within the last 5 years

Women of childbearing potential with a positive pregnancy test

Timeline

Screening 3 weeks

Treatment Varies

Follow Up multiple times from baseline through month 12

Summary

This trial is testing a new treatment called NCS-01 to see if it is safe for patients who have recently had a stroke. The study will check how well patients tolerate the treatment.

Who is the study for?

This trial is for men and women aged 18-85 who've had a recent stroke with certain levels of neurological deficits. They must be able to undergo an MRI, not have cancer in the last 5 years, no organ transplants, not in another drug study recently, and women must use birth control.

What is being tested?

The trial is testing NCS-01's safety and how well it's tolerated in those with acute ischemic stroke. Patients are randomly chosen to receive this treatment within 48 hours after their stroke starts. The study has two stages and includes multiple centers.

What are the potential side effects?

Since this is a Phase1/2 trial primarily focused on safety and tolerability, specific side effects of NCS-01 aren't listed but may include typical reactions related to immune response or infusion procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have some difficulty moving due to my stroke.

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I have had a stroke affecting one side of my brain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had any other cancers in the last 5 years.

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I am of childbearing age and my pregnancy test is positive.

Select...

I needed help with daily activities before my recent stroke.

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My neurological condition is getting worse.

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I have had an organ transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ multiple times from baseline through month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~multiple times from baseline through month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and multiple times from baseline through month 12 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

National Institutes of Health Stroke Scale (NIHSS)

Number of participants with adverse events -Safety by Incidence of Treatment-Emergent Adverse Events

Number of participants with change in Electrocardiography (ECG)

+2 more

Secondary study objectives

Number of participants with change in Barthel Index

Number of participants with change in Cytokine panel (IL-1, 6, 8, etc.)

Number of participants with change in MRI

+1 more

Other study objectives

Number of participants with change in Domain-specific Scales (Fugl-Meyer)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NCS-01Experimental Treatment1 Intervention

human bone marrow derived cells

Group II: shamPlacebo Group1 Intervention

sham procedure

0 / 7Eligibility criteria met

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 stroke include neuroprotective and thrombolytic agents. Neuroprotective agents work by inhibiting pathways that lead to cell death, reducing inflammation, and maintaining cellular function, thereby protecting brain tissue from damage. Thrombolytic agents dissolve blood clots that obstruct blood flow to the brain, restoring circulation and minimizing brain damage. These treatments are crucial for stroke patients as they can significantly reduce brain injury, improve recovery outcomes, and decrease the likelihood of long-term disability.