Chronic Ischemic StrokePhase 1NCT06299033
A Safety and Tolerability Study of Human Forebrain Neural Progenitor Cells Injection (hNPC01) in Subjects With Chronic Ischemic Stroke
A Phase 1 study testing hNPC01 in people with Chronic Ischemic Stroke, run by Hopstem Biotechnology Inc. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Chronic Ischemic Stroke
- What is being tested?
- hNPC01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 9 Nov 2023to 30 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- 6 - 60 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;
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- 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.
Who cannot join
- Has any psychological or psychiatric condition that would significantly interfere with the study;
- History of more than one symptomatic stroke [transient ischemic attacks (TIAs) are not exclusionary];
- 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;
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- 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;
- Laboratory values meeting any of the following criteria (a second retest can be performed for patients with a first test result outside the specified range, and the patients can be included in the study if the second test results are evaluated by the investigator as normal):
- Hemoglobin <90 g/L
- White blood cell count (WBC)<3.5×10^9/L
- Neutrophil count <1.5×10^9/L
- Platelet count <100×10^9/L
- Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) 2 times the upper limit of normal (ULN)
- Serum creatinine >1.2 × ULN
- Uncontrolled or poorly controlled hypertension despite medicine (systolic blood pressure >160 mmHg, or diastolic blood pressure >100 mmHg) or hypotension requiring pressor therapy;
- Uncontrolled or poorly controlled diabetes despite medicine (glycosylated hemoglobin A1c > 8%);
- Active gastrointestinal bleeding;
- Positive active pulmonary tuberculosis (if positive γ-interferon release test in screening period and the safety risk is within a controllable range after evaluation by the investigators, the participant can be enrolled);
- Active hepatitis B patients, including positive Hepatitis B surface antigens (HBsAg), and patients who had hepatitis B virus (HBV) infection in the past and whose HBV infection has disappeared (defined as hepatitis B core antibody [HBcAb] positive and HBsAg negative) meet the inclusion criteria;
- Hepatitis C virus antibody positive;
- Syphilis infected subjects (subjects who test positive for Treponema pallidum serology need to undergo further non-Treponema pallidum serology tests. If the test result is negative, the investigators determine that patients who have previously been infected with syphilis but have recovered meet the inclusion criteria);
- HIV antibody positive
- Primary or secondary immunodeficiency; or any medical condition involving immunosuppressants intake;
- Persistent MRI artifacts, no clear MRI images can be obtained before or after surgery; patients with contraindications to MRI or PET scans;
- Contraindications to cyclosporine or methylprednisone sodium succinate or prednisone;
- Neither able or willing to participate in physical and/or professional therapy as scheduled, nor to return to the hospital on time for follow-up visits as planned;
- Inability to discontinue antiplatelet or anticoagulant medications within the perioperative period;
- Existence of recent drug abuse or alcohol abuse or any other medical conditions that, in the opinion of the investigator, could interfere with the clinical study results or compromise the clinical condition of the subject, or which in the opinion of the investigator, could increase procedural complications.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
XiangYa Hospital
Changsha, Hunan
Dan Li, 15074875481
Zhiquan Yang, MD, PhD
About this study
Official title: A Phase 1 Dose-escalation, Single-Center, Open-labeled Study to Evaluate the Safety and Tolerability of Human Induced Pluripotent Stem Cell-derived Human Forebrain Neural Progenitor Cell Injection (hNPC01) in Chronic Ischemic Stroke
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.
Read the detailed description
The primary aims of this open-label single-armed study is to evaluate the safety and tolerability up to 4 cohorts of escalating doses of hNPC01 administered at a single dose via intracerebral injection to subjects with chronic cerebral ischemic stroke, and to determine MTD. The exploratory aim is to explore the evaluation tools with preliminary efficacy assessment and the potential of hNPC01 to mitigate the symptoms, especially motor symptoms associated with chronic stroke. Eligible participants for this study are individuals who have experienced a single ischemic stroke 6 to 60 months prior of enrollment and have exhibited no significant improvement following standard physical therapy interventions.
- Conditions
- Chronic Ischemic Stroke
- Being tested
- hNPC01
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hNPC01Drug
hNPC01, human forebrain neural progenitor cell product, intracerebral injection
| Study group | Role | What they receive |
|---|---|---|
| hNPC01 therapy | Experimental | 1.5×10^7 hNPC01 cells; 3.0×10^7 hNPC01 cells; 6.0×10^7 hNPC01 cells Receives: Drug: hNPC01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events as assessed by physiological parameters during 6 months after intracerebral injection of hNPC01
Measured: 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
Measured: during 12 months after intracerebral hNPC01 injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start9 Nov 2023
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopstem Biotechnology Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299033
- Sponsor's protocol ID
- HPS-NP1-101
- Status last verified
- Mar 2024
- First submitted
- 27 Jan 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose-escalation, Single-Center, Open-labeled Study to Evaluate the Safety and Tolerability of Human Induced Pluripotent Stem Cell-derived Human Forebrain Neural Progenitor Cell Injection (hNPC01) in Chronic Ischemic Stroke
- ClinicalTrials.gov ID
- NCT06299033
- Acronym / sponsor ID
- HPS-NP1-101
- Conditions
- Chronic Ischemic Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Hopstem Biotechnology Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary aims of this open-label single-armed study is to evaluate the safety and tolerability up to 4 cohorts of escalating doses of hNPC01 administered at a single dose via intracerebral injection to subjects with chronic cerebral ischemic stroke, and to determine MTD. The exploratory aim is to explore the evaluation tools with preliminary efficacy assessment and the potential of hNPC01 to mitigate the symptoms, especially motor symptoms associated with chronic stroke. Eligible participants for this study are individuals who have experienced a single ischemic stroke 6 to 60 months prior of enrollment and have exhibited no significant improvement following standard physical therapy interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hNPC01 therapy | Experimental | Drug: hNPC011.5×10^7 hNPC01 cells; 3.0×10^7 hNPC01 cells; 6.0×10^7 hNPC01 cells |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
- 6 - 60 months since the acute onset of ischemic stroke, accompanied by unilateral limb motor dysfunction, with/without aphasia;
Key exclusion criteria (37 listed)
- Has any psychological or psychiatric condition that would significantly interfere with the study;
- History of more than one symptomatic stroke [transient ischemic attacks (TIAs) are not exclusionary];
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hNPC01hNPC01, human forebrain neural progenitor cell product, intracerebral injection | Drug | hNPC01 therapy |
Primary outcome
Incidence of Treatment-Emergent Adverse Events as assessed by physiological parameters during 6 months after intracerebral injection of hNPC01
Time frame: during 6 months after intracerebral hNPC01 injection
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events as assessed by physiological parameters during 12 months after intracerebral injection of hNPC01
Time frame: during 12 months after intracerebral hNPC01 injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing hNPC01 in people with Chronic Ischemic Stroke, run by Hopstem Biotechnology Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuning Zhang, Ph.D (+86 571-88197776, shuningzh@hopstem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events as assessed by physiological parameters during 6 months after intracerebral injection of hNPC01 (time frame: during 6 months after intracerebral hNPC01 injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.