Ischemic Stroke in the Sequelae StagePhase 2NCT07841496

ALT001 in Patients With Ischemic Stroke in the Sequelae Stage

A Phase 2 study testing ALT001 in people with Ischemic Stroke in the Sequelae Stage, run by Darwin Origin (Hubei) Biopharmaceutical Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Ischemic Stroke in the Sequelae Stage
What is being tested?: ALT001
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 200 participants
Where: 1 siteChina
Study dates: 21 Sep 2026to 31 Oct 2027
Phase: Phase 2
Are there results?: Not yet: the study is under way

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 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants must meet all of the following criteria to be eligible for enrollment in this study:
Male or female participants aged 18 to 80 years, inclusive (determined at the time of signing the informed consent form);
A history of acute ischemic stroke confirmed by CT or MRI, with the most recent stroke occurring ≥180 days and no more than 5 years prior to enrollment;
Unilateral limb weakness, with a total Fugl-Meyer Motor score ≤90;
Modified Ashworth Scale score ≤2;
Premorbid mRS ≤1 (i.e., independence in daily living prior to the most recent stroke);
On a stable-dose standard treatment for secondary prevention of ischemic stroke (antiplatelet agents, statins, etc.) for at least 1 month prior to enrollment;
Participants must be willing and able to participate in the study, sign the informed consent form, and commit to completing all study-related procedures and visits in accordance with the protocol.

Who cannot join

Participants who meet any of the following criteria will be excluded from this study:
The culprit lesion of the most recent stroke is a posterior circulation infarct on imaging;
Baseline head CT or MRI showing malformations, tumors, abscesses, or other major non-vascular brain diseases (e.g., multiple sclerosis, dementia, Parkinson's disease, and other neurodegenerative diseases);
A cerebrovascular or cardiovascular event within the past 3 months, such as transient ischemic attack (TIA) or acute coronary syndrome (ACS);
History of recurrent seizures or epilepsy;
Allergic constitution (allergies to multiple drugs and foods), history of severe allergic/hypersensitivity reactions, or, in the investigator's judgment, potential allergy to the investigational drug or any of its components (e.g., history of allergy to protein-based drugs);

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At screening: positive for hepatitis B surface antigen (HBsAg) with HBV-DNA above the upper limit of normal (ULN) (if HBsAg is negative, HBV-DNA testing is not required); positive for hepatitis C antibody (anti-HCV) with HCV-RNA above the ULN (if anti-HCV is negative, HCV-RNA testing is not required); positive for human immunodeficiency virus (HIV) antibody; or positive for Treponema pallidum antibody;
Severe hepatic impairment (defined as ALT ≥3 × ULN or AST ≥3 × ULN); severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m²); severe heart failure (New York Heart Association [NYHA] class III-IV); or coagulation disorders or a history of systemic bleeding;
Poorly controlled blood glucose or blood pressure despite systematic treatment (HbA1c ≥8.5%; systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg);
At screening, severe autoimmune diseases, myeloproliferative disorders, leukemia or lymphoma, malignant tumors, fractures, or severe scoliosis that, in the investigator's judgment, would affect the study evaluation;
Significant cognitive impairment (per MMSE: ≤19 for the illiterate group, ≤22 for the primary school group, ≤26 for the junior high school and above group [>8 years of education]), or other unstable psychiatric conditions that, in the investigator's judgment, render the participant unsuitable for the study (including suicidal ideation, untreated major depression, etc.), or aphasia (aphasia severity grade 0) such that the participant cannot understand and/or comply with the study procedures;
Women who are pregnant or breastfeeding, or participants planning to conceive during the treatment period or within 3 months after treatment discontinuation;
Alcohol dependence or a history of drug abuse within 6 months prior to screening that, in the investigator's judgment, renders the participant unsuitable for this study;
Use of neuroprotective agents within 14 days prior to randomization, such as butylphthalide, edaravone, edaravone dexborneol, urinary kallidinogenase, citicoline, cerebroprotein hydrolysate, etc., or use of traditional Chinese medicine preparations with an indication of stroke;
Participation in another clinical trial with use of any other investigational drug or device within 3 months prior to screening; or prior receipt of stem cell therapy or gene therapy;
Patients who, in the investigator's judgment, are unsuitable for participation in this study (e.g., clinically significant abnormalities on physical examination or laboratory tests).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ning Wu, Director of Clinical Operations contact

+86-18228071008

wuning@darwincell.net

China1 site

Capital Medical University Affiliated Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
Yilong Wang, MD, Principal Investigator, +86 139 1166 6571, yilong528@gmail.com

Other trials in China

About this study

Official title: A Randomised, Double-blind, Placebo-controlled, Multicentre, Phase II Clinical Study to Evaluate the Efficacy and Safety of ALT001 in Patients With Ischemic Stroke in the Sequelae Stage

This is a phase II, randomized, double-blind, placebo-controlled, multicentre clinical study to evaluate the efficacy and safety of ALT001 in patients with ischemic stroke in the sequelae stage (≥180 days and ≤5 years after the most recent event). A total of 200 participants will be randomized 1:1:1:1 to receive ALT001 at 65 μg/day, 130 μg/day, or 260 μg/day, or matching placebo, by intravenous infusion once daily (over ~60 minutes) using a 14-day-on / 14-day-off cycle for 3 cycles (12 weeks) in the double-blind (DB) period, followed by an optional open-label extension (OLE) period of 3 additional cycles. The primary endpoint is the change from baseline in the Fugl-Meyer Assessment (FMA) motor score at Week 12.

Read the detailed description

Ischemic stroke (IS) is the most common type of stroke, yet for patients with persistent neurological deficits beyond 6 months (sequelae stage) there is no widely accepted effective therapy. ALT001 is an allogeneic unrelated human umbilical cord mesenchymal stem cell-derived protein complex intended to promote neurological repair. This phase II study enrolls adults (18-80 years) with unilateral limb weakness (FMA motor score ≤90) and modified Ashworth spasticity ≤2, at least 180 days but no more than 5 years after the most recent ischemic stroke. Participants are randomized to one of three ALT001 dose groups (65, 130, or 260 μg/day) or matching placebo. Study drug is reconstituted in 100 mL normal saline and given by IV infusion once daily over ~60 minutes, 14 days on / 14 days off per cycle, for 3 cycles in the DB period. Eligible participants may then enter a 3-cycle OLE period (placebo group re-randomized to an active dose). Efficacy is assessed by FMA (primary, Week 12), mRS, NIHSS, Barthel Index, and modified Ashworth scale; safety by AE/SAE monitoring; exploratory outcomes include new vascular events and immunologic/cytokine changes.

Conditions: Ischemic Stroke in the Sequelae Stage
Being tested: ALT001, Placebo (ALT001 matching placebo)
Keywords: Ischemic Stroke in the Sequelae Stage, Phase II

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ALT001Drug
A total of 150 participants in the active treatment arm were randomized in a 1:1:1 ratio to the 65 μg/day ALT001 treatment group, the 130 μg/day ALT001 treatment group, or the 260 μg/day ALT001 treatment group, with 50 participants in each group. For each treatment group, according to the assigned dose, ALT001 was dissolved in 100 mL of normal saline injection and administered by intravenous infusion once daily, completed within approximately 60 minutes.
Dosing schedule: Fourteen days of continuous dosing followed by 14 days off constituted one cycle. The DB period consisted of 3 consecutive cycles, Participants who complete the DB period will enter the OLE treatment period, using the same administration method as in the DB period. The active treatment groups will continue to receive the dose level of their assigned dose group, and the OLE period consisted of 3 consecutive cycles.
Placebo (ALT001 matching placebo)Other
The placebo group consisted of 50 participants. The placebo was dissolved in 100 mL of normal saline injection and administered by intravenous infusion once daily, completed within approximately 60 minutes.
Dosing schedule: Fourteen days of continuous dosing followed by 14 days off constituted one cycle. The DB period consisted of 3 consecutive cycles, and the OLE period consisted of 3 consecutive cycles.
Participants who complete the DB period will enter the OLE treatment period. The placebo group will be randomly assigned to the 3 dose groups and receive treatment for 3 consecutive cycles (12 weeks).

Study groups in NCT07841496
Study group	Role	What they receive
ALT001 65 μg/day	Experimental	A total of 50 participants in the active treatment arm. ALT001 65 μg/day (~1.0 μg/kg), reconstituted in 100 mL normal saline, IV infusion once daily over ~60 minutes; 14 days on / 14 days off per cycle; 3 cycles in DB period. Receives: Drug: ALT001
ALT001 130 μg/day	Experimental	A total of 50 participants in the active treatment arm. ALT001 130 μg/day (~2.0 μg/kg), same administration schedule as Arm 1. Receives: Drug: ALT001
ALT001 260 μg/day	Experimental	A total of 50 participants in the active treatment arm. ALT001 260 μg/day (~4.0 μg/kg), same administration schedule as Arm 1. Receives: Drug: ALT001
Placebo	Placebo comparator	ALT001 matching placebo (simulator) without active ingredient, same administration schedule; in the OLE period, placebo-group participants are re-randomized to one of the three active dose groups for 3 cycles (12 weeks). Receives: Other: Placebo (ALT001 matching placebo)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in Fugl-Meyer Assessment (FMA) motor score
The Fugl-Meyer Assessment (FMA) is used to evaluate the motor function of patients with ischemic stroke. It comprises an upper-extremity motor function subscore (66 points) and a lower-extremity motor function subscore (34 points), for a total of 100 points. Total-score grading: 0-49 = severe motor impairment; 50-84 = marked motor impairment; 85-95 = moderate motor impairment; 96-99 = mild motor impairment.
Measured: Week 12 (double-blind period)

Secondary outcomes (6)

Change from baseline in the Fugl-Meyer Assessment (FMA) Motor score
The Fugl-Meyer Assessment (FMA) is used to evaluate the motor function of patients with ischemic stroke. It comprises an upper-extremity motor function subscore (66 points) and a lower-extremity motor function subscore (34 points), for a total of 100 points. Total-score grading: 0-49 = severe motor impairment; 50-84 = marked motor impairment; 85-95 = moderate motor impairment; 96-99 = mild motor impairment.
Measured: After 4 and 8 weeks of treatment during the double-blind treatment period
Change from baseline in modified Rankin Scale (mRS) distribution / proportion of patients by mRS grade
The modified Rankin Scale (mRS) is a global outcome measure of disability and functional independence after stroke, graded on an ordinal scale from 0 to 6: 0 = no symptoms, 1 = no clinically significant disability, 2 = slight disability, 3 = moderate disability (requires some help), 4 = moderately severe disability (unable to walk unassisted), 5 = severe disability (bedridden, requiring constant care), and 6 = death. The mRS score range is 0 to 6; higher scores indicate worse outcome (greater disability). The proportion of patients in each mRS grade and the shift in mRS distribution from baseline will be summarized at Weeks 4, 8, and 12.
Measured: Weeks 4, 8, and 12
Change from baseline in National Institutes of Health Stroke Scale (NIHSS) score
Difference in NIHSS score from baseline to Weeks 4, 8, and 12 of the double-blind treatment period. The National Institutes of Health Stroke Scale (NIHSS) is an ordinal scale used to quantify neurological impairment in stroke patients, assessing 11 domains including level of consciousness, gaze, visual fields, facial palsy, motor function of the arms and legs, limb ataxia, sensory loss, language (aphasia), dysarthria, and inattention (extinction/inattention). The NIHSS score range is 0 to 42, with lower scores indicating less severe neurological impairment. Higher scores indicate worse outcome (more severe neurological deficit).
Measured: Weeks 4, 8, and 12
Change from baseline in Barthel Index (BI) score
Difference in Barthel Index (BI) score from baseline to Weeks 4, 8, and 12 of the double-blind treatment period. The Barthel Index (BI) is an ordinal scale that measures functional independence in activities of daily living (ADL), assessing 10 items: feeding, bathing, grooming, dressing, bowel control, bladder control, toilet use, transfers, mobility, and stairs. Each activity is scored on a 5-level scale, with level 1 being the lowest and level 5 the highest. A higher level indicates a greater degree of independence. The BI score range is 0 to 100, with higher scores indicating better outcome (greater independence in daily living).
Measured: Weeks 4, 8, and 12
Change from baseline in the Modified Ashworth Scale (MAS) score
The Modified Ashworth Scale (MAS) is used to assess muscle tone and degree of spasticity during passive movement of skeletal muscles; the investigator performs passive stretching of the target muscle group and grades the increase in tone and resistance to passive movement. Scoring ranges from grade 0 to grade 4, with grade 1+ indicating a slight increase in tone with resistance intermediate between grade 1 and grade 2 (numeric range 0 to 4). Higher scores indicate worse outcome (more severe spasticity). In this study, six movements are assessed separately: upper limb - elbow flexion, wrist flexion, forearm pronation; lower limb - knee extension, knee flexion, ankle plantar flexion. Assessed once per cycle during the 3-cycle OLE period.
Measured: Weeks 4, 8, and 12
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), summarized by system organ class and preferred term (MedDRA coded), and graded according to CTCAE v5.0. Events are collected from the first dose of study drug through the 28-day post-treatment safety follow-up and reported for the double-blind period, the open-label extension period, and the overall treatment period.
Measured: Through study completion, up to approximately 28 weeks (up to 24 weeks of treatment, comprising the 12-week double-blind period and the 12-week open-label extension period, plus a 28-day safety follow-up after the last dose).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Sep 202631 Oct 2027

First posted25 Sep 2026
Study start21 Sep 2026 (estimated)
Primary completion30 Jun 2027 (estimated)
Study completion31 Oct 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Ischemic Stroke in the Sequelae StageStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 200 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07841496
Sponsor's protocol ID: ALT001-CN-IND-02002
Status last verified: Sep 2026
First submitted: 7 Sep 2026
Last updated: 25 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Placebo-controlled, Multicentre, Phase II Clinical Study to Evaluate the Efficacy and Safety of ALT001 in Patients With Ischemic Stroke in the Sequelae Stage
ClinicalTrials.gov ID: NCT07841496
Acronym / sponsor ID: ALT001-CN-IND-02002
Conditions: Ischemic Stroke in the Sequelae Stage
Keywords: Ischemic Stroke in the Sequelae Stage, Phase II
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 200 participants (estimated)
Lead sponsor: Darwin Origin (Hubei) Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 21 Sep 2026 (estimated)
Primary completion: 30 Jun 2027 (estimated)
Study completion: 31 Oct 2027 (estimated)
First posted: 25 Sep 2026 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
ALT001 65 μg/day	Experimental	Drug: ALT001A total of 50 participants in the active treatment arm. ALT001 65 μg/day (~1.0 μg/kg), reconstituted in 100 mL normal saline, IV infusion once daily over ~60 minutes; 14 days on / 14 days off per cycle; 3 cycles in DB period.
ALT001 130 μg/day	Experimental	Drug: ALT001A total of 50 participants in the active treatment arm. ALT001 130 μg/day (~2.0 μg/kg), same administration schedule as Arm 1.
ALT001 260 μg/day	Experimental	Drug: ALT001A total of 50 participants in the active treatment arm. ALT001 260 μg/day (~4.0 μg/kg), same administration schedule as Arm 1.
Placebo	Placebo comparator	Other: Placebo (ALT001 matching placebo)ALT001 matching placebo (simulator) without active ingredient, same administration schedule; in the OLE period, placebo-group participants are re-randomized to one of the three active dose groups for 3 cycles (12 weeks).

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Participants must meet all of the following criteria to be eligible for enrollment in this study:
Male or female participants aged 18 to 80 years, inclusive (determined at the time of signing the informed consent form);
A history of acute ischemic stroke confirmed by CT or MRI, with the most recent stroke occurring ≥180 days and no more than 5 years prior to enrollment;
Unilateral limb weakness, with a total Fugl-Meyer Motor score ≤90;
Modified Ashworth Scale score ≤2;

Key exclusion criteria (16 listed)

The culprit lesion of the most recent stroke is a posterior circulation infarct on imaging;
Baseline head CT or MRI showing malformations, tumors, abscesses, or other major non-vascular brain diseases (e.g., multiple sclerosis, dementia, Parkinson's disease, and other neurodegenerative diseases);
A cerebrovascular or cardiovascular event within the past 3 months, such as transient ischemic attack (TIA) or acute coronary syndrome (ACS);
History of recurrent seizures or epilepsy;
Allergic constitution (allergies to multiple drugs and foods), history of severe allergic/hypersensitivity reactions, or, in the investigator's judgment, potential allergy to the investigational drug or any of its components (e.g., history of allergy to protein-based drugs);

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
ALT001A total of 150 participants in the active treatment arm were randomized in a 1:1:1 ratio to the 65 μg/day ALT001 treatment group, the 130 μg/day ALT001 treatment group, or the 260 μg/day ALT001 treatment group, with 50 participants in each group. For each treatment group, according to the assigned dose, ALT001 was dissolved in 100 mL of normal saline injection and administered by intravenous infusion once daily, completed within approximately 60 minutes. Dosing schedule: Fourteen days of continuous dosing followed by 14 days off constituted one cycle. The DB period consisted of 3 consecutive cycles, Participants who complete the DB period will enter the OLE treatment period, using the same administration method as in the DB period. The active treatment groups will continue to receive the dose level of their assigned dose group, and the OLE period consisted of 3 consecutive cycles.	Drug	ALT001 130 μg/day, ALT001 260 μg/day, ALT001 65 μg/day
Placebo (ALT001 matching placebo)The placebo group consisted of 50 participants. The placebo was dissolved in 100 mL of normal saline injection and administered by intravenous infusion once daily, completed within approximately 60 minutes. Dosing schedule: Fourteen days of continuous dosing followed by 14 days off constituted one cycle. The DB period consisted of 3 consecutive cycles, and the OLE period consisted of 3 consecutive cycles. Participants who complete the DB period will enter the OLE treatment period. The placebo group will be randomly assigned to the 3 dose groups and receive treatment for 3 consecutive cycles (12 weeks).	Other	Placebo

Primary outcome

Change from baseline in Fugl-Meyer Assessment (FMA) motor score
Time frame: Week 12 (double-blind period)
The Fugl-Meyer Assessment (FMA) is used to evaluate the motor function of patients with ischemic stroke. It comprises an upper-extremity motor function subscore (66 points) and a lower-extremity motor function subscore (34 points), for a total of 100 points. Total-score grading: 0-49 = severe motor impairment; 50-84 = marked motor impairment; 85-95 = moderate motor impairment; 96-99 = mild motor impairment.

6 secondary outcomes

Change from baseline in the Fugl-Meyer Assessment (FMA) Motor score
Time frame: After 4 and 8 weeks of treatment during the double-blind treatment period
Change from baseline in modified Rankin Scale (mRS) distribution / proportion of patients by mRS grade
Time frame: Weeks 4, 8, and 12
Change from baseline in National Institutes of Health Stroke Scale (NIHSS) score
Time frame: Weeks 4, 8, and 12
Change from baseline in Barthel Index (BI) score
Time frame: Weeks 4, 8, and 12
Change from baseline in the Modified Ashworth Scale (MAS) score
Time frame: Weeks 4, 8, and 12
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Through study completion, up to approximately 28 weeks (up to 24 weeks of treatment, comprising the 12-week double-blind period and the 12-week open-label extension period, plus a 28-day safety follow-up after the last dose).

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
Individual participant dataSharing planned: No

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.

Ning Wu, Director of Clinical Operations contact

+86-18228071008

wuning@darwincell.net

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ALT001 in people with Ischemic Stroke in the Sequelae Stage, run by Darwin Origin (Hubei) Biopharmaceutical Co., Ltd. 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 8 inclusion and 16 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: opening soon, as of the sponsor's last update on 25 Sep 2026. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ning Wu, Director of Clinical Operations (+86-18228071008, wuning@darwincell.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Fugl-Meyer Assessment (FMA) motor score (time frame: Week 12 (double-blind period)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07841496.

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 25 Sep 2026.