A Safety and Tolerability Study of Human Forebrain Neural Progenitor Cells Injection (hNPC01) in Subjects With Chronic Ischemic Stroke

NCT06299033 | Recruiting Phase 1 DMC

• 1 other identifier: HPS-NP1-101
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The principal aims of the clinical investigation involve assessing the safety profile and MTD of human forebrain neural progenitor cells (hNPC01) administered at escalated doses via single-dose intracerebral injection to subjects with stable chronic ischemic stroke.

Conditions

Chronic Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events as assessed by physiological parameters during 6 months after intracerebral injection of hNPC01

  during 6 months after intracerebral hNPC01 injection

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events as assessed by physiological parameters during 12 months after intracerebral injection of hNPC01

  during 12 months after intracerebral hNPC01 injection

Other Outcomes (4)

• Number of participants with motor function improvement as assessed by rating scales of Modified Rankin Scale (mRS) during 12 months of treatment

  during 12 months after intracerebral hNPC01 injection

• Number of participants with motor function improvement as assessed by rating scales of Fugl-Meyer Motor Scale (FMMS) during 12 months of treatment

  during 12 months after intracerebral hNPC01 injection

• Number of participants with motor function improvement as assessed by rating scales of NIH Stroke Scale (NIHSS) during 12 months of treatment

  during 12 months after intracerebral hNPC01 injection

Study Arms (1)

hNPC01 therapy

EXPERIMENTAL

1.5×10\^7 hNPC01 cells; 3.0×10\^7 hNPC01 cells; 6.0×10\^7 hNPC01 cells

Drug: hNPC01

Interventions

hNPC01 DRUG

hNPC01, human forebrain neural progenitor cell product, intracerebral injection

hNPC01 therapy

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject or his/her legal guardian must understand and voluntarily sign an Informed Consent Form (ICF) prior to any study-related assessments/procedure being conducted;
• Age 30-65 years old, male or female; at the time of signing the ICF;
• Female patients with negative blood pregnancy test and women in the reproductive period need to adopt effective contraceptive methods; Or has become infertile (menopausal for at least 2 years or has undergone hysterectomy, oophorectomy, or sterilization surgery); Male patients who have no plans to donate sperm or have children within 30 days before the trial and six months after the trial end need to adopt effective contraceptive methods;
• Documented history of completed ischemic stroke in the subcortical and/or cortical regions of the middle cerebral artery (MCA) or lenticulostriate arteries confirmed by head CT or magnetic resonance imaging;
• months since the acute onset of ischemic stroke, accompanied by unilateral limb motor dysfunction, with/without aphasia;
• Modified Rankin Score 3, or 4 points at time of screening;
• FMMS scores lower than 55 and score changes no greater than 5 points in two assessments at least 3 weeks apart before surgery;
• NIHSS score change is no greater than 4 points in two assessments at least 3 weeks apart before surgery;
• Subject must have maintained regular physical therapy and rehabilitation prior to enrollment and be able to continue physical therapy and rehabilitation after treatment.

You may not qualify if:

• Has any psychological or psychiatric condition that would significantly interfere with the study;
• Has signs and symptoms of intracerebral hernia or elevated intracerebral pressure;
• History of epilepsy or current use of antiepileptic drugs, including any seizures in the 3 months prior to screening;
• Intracerebral aneurysm or arteriovenous malformation; hemorrhagic transformation of ischemic loci within 2 weeks of screening; moyamoya disease (MMD); autosomal dominant cerebrovascular disease with subcortical infarction and leukoencephalopathy; patients with giant cerebral infarction (MRI confirms that the infarct size is greater than 150 cm\^3); CT angiography (CTA) shows severe stenosis in vital vessels in head or neck;
• Patients with severely impaired motor function of one limb caused by previous neurological diseases (such as PD, motor neuron disease, arthritis, or anatomical deformity, etc.); Patients who have undergone any major surgery 8 weeks prior to screening;
• Severe muscular atrophy or muscular dystrophy;
• Patients with severe cardiovascular diseases within 3 months of screening, such as malignant arrhythmia, atrial fibrillation, acute myocardial infarction, congestive heart failure, etc. (cardiac function grade III-IV using the New York Heart Association (NYHA) classification for heart failure);
• Patients participating in other drug or device clinical trials within the last 3 months or 5 half-lives of the drug, whichever is longer;
• Receiving other cell transfusions or alike other than transfusion in the past 5 years;
• Any of the following diseases or conditions:
• Severe coagulopathy, preoperative INR (International Normalized Ratio)\>1.4;
• Patients with positive HLA (Human Leukocyte Antigen) before surgery;
• Severe active infection with poor drug control before surgery;
• Severe dermatitis or severe skin damage in the operation area;
• History of tumors other than benign tumors; history of brain tumors, including meningiomas;

Sponsors & Collaborators

• Hopstem Biotechnology Inc.: lead

Study Sites (1)

XiangYa Hospital

Changsha, Hunan, China

RECRUITING

Central Study Contacts

Shuning Zhang, Ph.D

CONTACT

+86 571-88197776; shuningzh@hopstem.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2024
• First Posted: March 7, 2024
• Study Start: November 9, 2023
• Primary Completion: August 30, 2024
• Study Completion: December 30, 2025
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

CN (1)