A Phase 2 interventional study of ALT001 and Placebo (ALT001 matching placebo) in Ischemic Stroke in the Sequelae Stage, sponsored by Darwin Origin (Hubei) Biopharmaceutical Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Darwin Origin (Hubei) Biopharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment
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.
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.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 200 is above the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Darwin Origin (Hubei) Biopharmaceutical Co., Ltd. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants must meet all of the following criteria to be eligible for enrollment in this study:
Exclusion Criteria:
Participants who meet any of the following criteria will be excluded from this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: ALT001
A total of 50 participants in the active treatment arm. ALT001 130 μg/day (\~2.0 μg/kg), same administration schedule as Arm 1.
Drug: ALT001
A total of 50 participants in the active treatment arm. ALT001 260 μg/day (\~4.0 μg/kg), same administration schedule as Arm 1.
Drug: ALT001
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).
Other: Placebo (ALT001 matching placebo)
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.
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).
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.
Time frame: Week 12 (double-blind period)
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.
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
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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
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).
Incidence of new-onset vascular events (new-onset stroke, myocardial infarction, and vascular death)
New-onset stroke, myocardial infarction, and vascular death occurring from first dose through the 28-day post-treatment follow-up will be adjudicated/confirmed by \[the investigator and/or an independent endpoint adjudication committee\] and reported as number and percentage of participants with each event type in each dose group.
Time frame: From first dose 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 post-treatment safety follow-up).
Concentration of cytokines in serum (IFN-γ, IL-10, IL-13, IL-1β, IL-2, IL-4, IL-5, IL-6, GRO-α, TNF-α, IL-2)
Serum concentrations of the following cytokines, measured by central laboratory assay: IFN-γ, IL-10, IL-13, IL-1β, IL-2, IL-4, IL-5, IL-6, GRO-α, TNF-α and IL-2. Concentrations are reported in pg/mL for each cytokine. This outcome measure reports laboratory analyte concentrations, not a score on a scale; therefore an unabbreviated scale title, minimum/maximum score, and score direction do not apply.
Time frame: Baseline and Week 12 (double-blind period); Week 12 and Week 24 (open-label extension period)
Concentration of immunoglobulins in serum (IgG, IgM, IgA)
Serum concentrations of immunoglobulins IgG, IgM, and IgA measured by central laboratory assay, reported in mg/dL for each immunoglobulin. This outcome measure reports laboratory analyte concentrations, not a score on a scale.
Time frame: Baseline and Week 12 (double-blind period); Week 12 and Week 24 (open-label extension period)
Number and percentage of T-cell subsets in blood (CD3+CD4+, CD3+CD8+, CD28+, CD16+)
Enumeration of T-cell subsets (CD3+CD4+, CD3+CD8+, CD28+, CD16+) by flow cytometry, reported as cell counts and percentages of lymphocytes, including the CD3+CD4+/CD3+CD8+ ratio. This outcome measure reports cell counts/percentages, not a score on a scale.
Time frame: Baseline and Week 12 (double-blind period); Week 12 and Week 24 (open-label extension period)
Incidence of treatment-emergent anti-drug antibodies (ADA)
Number and percentage of participants with treatment-emergent anti-drug antibody (ADA) responses to ALT001, measured by central laboratory assay; ADA titre is reported where applicable. This outcome measure reports incidence and titre, not a score on a scale.
Time frame: Baseline and Week 12 (double-blind period); Week 12 and Week 24 (open-label extension period)
Change in modified Rankin Scale (mRS) score from Week 13 to the end of the open-label extension (OLE) period
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).
Time frame: Week 13 (OLE baseline) and Weeks 17, 21, and 24 (open-label extension period)
Change in National Institutes of Health Stroke Scale (NIHSS) score from Week 13 to the end of the open-label extension (OLE) 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).
Time frame: Week 13 (OLE baseline) and Weeks 17, 21, and 24 (open-label extension period)
Change in Barthel Index (BI) score from Week 13 to the end of the open-label extension (OLE) 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).
Time frame: Week 13 (OLE baseline) and Weeks 17, 21, and 24 (open-label extension period)
Change in Modified Ashworth Scale (MAS) score from Week 13 to the end of the open-label extension (OLE) period
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.
Time frame: Week 13 (OLE baseline) and Weeks 17, 21, and 24 (open-label extension period)
Change in Fugl-Meyer Assessment (FMA) motor score from Week 13 to the end of the open-label extension (OLE) period
The Fugl-Meyer Assessment (FMA) evaluates motor function in patients with ischemic stroke and comprises an upper-extremity motor subscore (0 to 66) and a lower-extremity motor subscore (0 to 34), for a total score range of 0 to 100. Per the protocol's total-score grading: 0-49 = severe, 50-84 = marked, 85-95 = moderate, 96-99 = mild motor impairment. Higher scores indicate better motor function.
Time frame: Week 13 (OLE baseline) and Weeks 17, 21, and 24 (open-label extension period)
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: ALT001
Darwin Origin (Hubei) Biopharmaceutical Co., Ltd.