NCS-01 for Stroke

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

16 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug NCS-01 for stroke?

Research on similar treatments, like the traditional Chinese medicine NeuroAiD (MLC601), shows that it can improve recovery after a stroke by reducing neurological deficits and enhancing motor recovery. This suggests that NCS-01 might also be effective in helping stroke patients recover. ^{1 2 3 4 5}

Is NCS-01 safe for use in humans?

Preclinical studies suggest that NCS-01 cells, derived from bone marrow, are safe and show promise in treating stroke by improving motor and neurological functions in animal models. These studies indicate that NCS-01 cells may be a safe option for future human trials. ^{1 6 7 8 9}

How is the NCS-01 treatment different from other stroke treatments?

NCS-01 is a novel cell-based therapy using bone marrow-derived cells that show promise in improving motor and neurological function after a stroke. Unlike traditional treatments, NCS-01 cells secrete therapeutic factors and extend filopodia (tiny projections) towards the injury site, potentially offering a unique mechanism for recovery. ^{1 6 10 11 12}

Research Team

Sean Savitz

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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 am between 18 and 85 years old.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Meta-Analysis and Systematic Review of Neural Stem Cells therapy for experimental ischemia stroke in preclinical studies. [2018]

2. Switzerland 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. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Effectiveness and Superiority of Rehabilitative Treatments in Enhancing Motor Recovery Within 6 Months Poststroke: A Systemic Review. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of MLC601 in Iranian Patients after Stroke: A Double-Blind, Placebo-Controlled Clinical Trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Control intervention design for preclinical and clinical trials: Consensus-based core recommendations from the third Stroke Recovery and Rehabilitation Roundtable. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Bone Marrow-Derived NCS-01 Cells Advance a Novel Cell-Based Therapy for Stroke. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Methodological quality of animal studies of neuroprotective agents currently in phase II/III acute ischemic stroke trials. [2021]

8. India pubmed.ncbi.nlm.nih.gov

Bone marrow-derived NCS-01 cells for ischemic stroke. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

A critical appraisal of the NXY-059 neuroprotection studies for acute stroke: a need for more rigorous testing of neuroprotective agents in animal models of stroke. [2014]

10. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of scalp acupuncture in improving neurological dysfunction after ischemic stroke: A protocol for systematic review and meta-analysis. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Exogenous Neural Stem Cells Transplantation as a Potential Therapy for Photothrombotic Ischemia Stroke in Kunming Mice Model. [2018]

12. Sweden pubmed.ncbi.nlm.nih.gov

Safety and efficacy of recovery-promoting drugs for motor function after stroke: A systematic review of randomized controlled trials. [2019]