NCS-01 for Stroke

Not currently recruiting at 1 trial location

Overseen By Martine Francis

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: NC Medial Research Inc

Disqualifiers: Malignancies, Organ transplant, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called NCS-01, which uses human bone marrow cells, to determine its safety and tolerability for individuals who have recently experienced an acute ischemic stroke. Researchers aim to find the right dose and assess how well NCS-01 works compared to a placebo (a non-active treatment). Individuals who have had a stroke within the last 48 hours and are experiencing noticeable problems, such as difficulty moving or speaking, might be suitable for this study. As a Phase 1/Phase 2 trial, the study focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

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

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

Research has shown that treatments using bone marrow cells, such as NCS-01, are generally safe for stroke patients. One study found that patients with long-term stroke who received similar cells for two years experienced no major safety issues. Another review confirmed the safety of these cells, though further research is needed to assess their effectiveness. Overall, these findings suggest that NCS-01 is likely safe for people, but ongoing trials will help confirm its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for stroke?

Researchers are excited about NCS-01 because it uses human bone marrow-derived cells, which is a novel approach for stroke treatment. Unlike traditional treatments that focus on dissolving clots or improving blood flow, NCS-01 aims to repair and regenerate damaged brain tissue, potentially offering a more comprehensive recovery. This regenerative approach could lead to better outcomes and faster recovery times for stroke patients compared to current options.

What evidence suggests that this trial's treatments could be effective for stroke?

Research has shown that NCS-01, derived from human bone marrow cells, could be a promising treatment for ischemic stroke. Studies have found that these cells aid recovery by reducing stroke-induced damage. In early tests, NCS-01 improved recovery in stroke models. This trial will compare NCS-01 to a placebo, serving as a control. Although further research is necessary, these early results suggest that NCS-01 could effectively address stroke-related issues. ^{1 5 6 7 8}

Who Is on the Research Team?

Sean Savitz

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Women of child bearing potential who agrees to take acceptable birth control as described in the ICF

Provide written informed consent before participation, either by patient or a legal representative

I have some difficulty moving due to my stroke.

Exclusion Criteria

You cannot have an MRI scan.

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

You have had a bad reaction to similar treatments before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Randomization and Initial Treatment

Participants are randomized within 48 hours of stroke onset and receive either the sham procedure or NCS-01 treatment

48 hours

1 visit (in-person)

Treatment and Monitoring

Participants undergo treatment and are monitored for changes in NIHSS, ECG, and adverse events

12 months

Multiple visits (in-person and virtual) throughout the study

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NCS-01
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: NCS-01 Experimental Treatment 1 Intervention

human bone marrow derived cells

Group II: sham Placebo Group 1 Intervention

sham procedure

Who Is Running the Clinical Trial?

NC Medial Research Inc

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

The CHIMES trial is investigating the long-term effects of the traditional Chinese medicine MLC601 (NeuroAiD) on reducing neurological deficits and improving functional outcomes in patients with acute ischemic stroke, with a focus on those with moderate severity (NIHSS scores of 6 to 14).

This extension study aims to assess the efficacy of NeuroAiD over a 2-year period, with a robust sample size of 1,100 participants, and is designed to provide strong evidence regarding its potential benefits compared to placebo in stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chinese medicine NeuroAiD efficacy stroke recovery-extension study (CHIMES-E study): an observational multicenter study to investigate the longer-term efficacy of NeuroAiD in stroke recovery. Venketasubramanian, N., Young, S., Tay, SS., et al.[2013]

In a double-blind, placebo-controlled trial involving 150 patients with recent ischemic stroke, MLC601 (NeuroAid) significantly improved motor recovery compared to placebo, as measured by the Fugl-Meyer assessment over 12 weeks (P < .001).

The treatment was well-tolerated, with only mild and transient adverse events reported, indicating that MLC601 is a safe addition to standard stroke therapies, particularly for patients with moderate to severe strokes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of MLC601 in Iranian Patients after Stroke: A Double-Blind, Placebo-Controlled Clinical Trial. Harandi, AA., Abolfazli, R., Hatemian, A., et al.[2022]

Among 178 studies analyzed, six experimental training programs (ETPs) were found to significantly improve upper extremity motor recovery in stroke patients, including constraint-induced movement therapy and mirror therapy, with effect sizes indicating moderate to strong benefits.

For lower extremity recovery, six ETPs, such as body-weight-supported treadmill training and caregiver-mediated training, also showed significant effectiveness; however, none of the ETPs demonstrated superiority over conventional training programs, suggesting that while they are beneficial, they may not be better than standard rehabilitation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Superiority of Rehabilitative Treatments in Enhancing Motor Recovery Within 6 Months Poststroke: A Systemic Review. Lin, IH., Tsai, HT., Wang, CY., et al.[2019]

A systematic review of 50 randomized controlled trials involving 4,779 citations found that 18 out of 28 drug interventions significantly improved motor recovery post-stroke compared to placebo, indicating potential efficacy of these treatments.

Despite the promising results, the high risk of bias in many studies raises concerns about the reliability of the findings, highlighting the need for further research to optimize drug interventions and their combination with physical therapy for better stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of recovery-promoting drugs for motor function after stroke: A systematic review of randomized controlled trials. Firth, N., Barker, RN., Hayward, KS., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8057097/

Bone marrow-derived NCS-01 cells for ischemic stroke - PMC Stem cell therapy serves as a viable treatment option and has been deemed as a safe and effective treatment for stroke patients. Adult human bone marrow-derived ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7215343/

Bone Marrow-Derived NCS-01 Cells Advance a Novel ... Preclinical studies using bone marrow-derived NCS-01 cells show the cells' ability to confer functional recovery in ischemic stroke. Coculturing ...

3. journals.lww.com journals.lww.com/brci/fulltext/2021/07010/bone_marrow_derived_ncs_01_cells_for_ischemic.11.aspx

Bone marrow-derived NCS-01 cells for ischemic stroke Adult human bone marrow-derived NCS-01 cells serve as a potential treatment for stroke given their ability to reduce stroke-induced pathological deficits.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0006899322003857

A comparative study of different doses of bone marrow ... Highlights. •. Different doses of human bone marrow-derived MSC was effective in the treatment of stroke-induced rats.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02425670

Stem Cell Therapy For Acute Ischemic Stroke Patients The purpose of this study is to determine whether patients with subacute ischemic stroke will benefit from infusion of patient's own bone marrow derived ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5828512/

Clinical Outcomes of Transplanted Modified Bone Marrow– ... Preclinical data suggest that cell-based therapies have the potential to improve stroke outcomes. Eighteen patients with stable, chronic stroke were ...

7. thejns.org thejns.org/view/journals/j-neurosurg/131/5/article-p1462.xml

Two-year safety and clinical outcomes in chronic ischemic ... In this completed 2-year phase 1/2a study, implantation of SB623 cells in patients with stable chronic stroke was safe and was accompanied by improvements in ...

8. link.springer.com link.springer.com/article/10.1007/s10072-023-07274-x

Safety and efficacy of bone marrow mononuclear cell ... Our meta-analysis demonstrated that the transplantation of BMMNCs was safe; however, the efficacy of this procedure requires further validation in larger RTCs.