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NCS-01 for Stroke

Q: How many volunteers have enrolled in the trial thus far?

Affirmative. The details available on clinicaltrials.gov verify that this medical study is currently taking enrolment applications, having originally been posted in February 2020 and updated most recently in April 2022. 16 participants are needed to be recruited from a single site.

Q: Does this clinical research include individuals aged 50 and above?

In accordance with the rules stipulated in this trial's inclusion criteria, it is obligatory that <a href="https://www.withpower.com/clinical-trials/all">all</a> participants are at least 18 years of age and no older than 80.

Q: To what extent does this investigation seek to accomplish?

According to the clinical trial sponsor, NC Medical Research Inc., one of the primary objectives is assessing participants' adverse reactions over a 1-hour, 3-hour and 6-hour post infusion period. Additionally, they will be measuring an array of secondary outcomes such as changes in <a href="https://www.withpower.com/clinical-trials/mri">MRI</a> data, Modified Rankin Scale scores and cytokine panel results (IL-1; IL-6; etc).

Q: What criteria must a participant fulfill to join this research investigation?

Candidates must meet the criteria of having a wake-up <a href="https://www.withpower.com/clinical-trials/stroke">stroke</a> and being between 18 - 80 years old to be qualified for this trial. Approximately 16 individuals will have the opportunity to join.

Q: Is there an ongoing enrollment period for this research trial?

Affirmative. According to clinicaltrials.gov, this research experiment is actively in search of participants and was initially posted on February 27th 2020 with the most recent update made April 22nd 2022. 16 individuals are needed across 1 facility for participation.

Phase 1 & 2

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up multiple times from baseline through month 12

Awards & highlights

Study Summary

This trial is testing a new stroke treatment to see if it is safe and effective. Patients will be given the new treatment or a placebo, and researchers will track how well they recover.

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.Check my eligibility

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.See study design

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

Select...

I have some difficulty moving due to my stroke.

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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 outcome measures

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

NC Medial Research IncLead Sponsor

Sean Savitz, mdPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Media Library

NCS-01 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT03915431 — Phase 1 & 2

Stroke Research Study Groups: sham, NCS-01

Stroke Clinical Trial 2023: NCS-01 Highlights & Side Effects. Trial Name: NCT03915431 — Phase 1 & 2

NCS-01 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03915431 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers have enrolled in the trial thus far?

"Affirmative. The details available on clinicaltrials.gov verify that this medical study is currently taking enrolment applications, having originally been posted in February 2020 and updated most recently in April 2022. 16 participants are needed to be recruited from a single site."

Answered by AI

Does this clinical research include individuals aged 50 and above?

"In accordance with the rules stipulated in this trial's inclusion criteria, it is obligatory that all participants are at least 18 years of age and no older than 80."

Answered by AI

To what extent does this investigation seek to accomplish?

"According to the clinical trial sponsor, NC Medical Research Inc., one of the primary objectives is assessing participants' adverse reactions over a 1-hour, 3-hour and 6-hour post infusion period. Additionally, they will be measuring an array of secondary outcomes such as changes in MRI data, Modified Rankin Scale scores and cytokine panel results (IL-1; IL-6; etc)."

Answered by AI

What criteria must a participant fulfill to join this research investigation?

"Candidates must meet the criteria of having a wake-up stroke and being between 18 - 80 years old to be qualified for this trial. Approximately 16 individuals will have the opportunity to join."

Answered by AI

Is there an ongoing enrollment period for this research trial?

"Affirmative. According to clinicaltrials.gov, this research experiment is actively in search of participants and was initially posted on February 27th 2020 with the most recent update made April 22nd 2022. 16 individuals are needed across 1 facility for participation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of NCS-01 in Patients With Acute Ischemic Stroke

2020. "A Study of NCS-01 in Patients With Acute Ischemic Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03915431.

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