Multiple System Atrophy - Parkinsonian Subtype (MSA-P)Early Phase 1SPRITENCT06765733
The Study of Safety and Preliminary Efficacy of Aleeto in Patients With MultIple System Atrophy
A Early Phase 1 study testing Aleeto in people with Multiple System Atrophy - Parkinsonian Subtype (MSA-P) and Multiple System Atrophy, MSA, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
This is a single-center, prospective, randomized, open-label, blinded outcome assessment (PROBE) study. At the end of the PROBE study, patients who have completed the study may opt to enter the open-label extension (OLE) study. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Multiple System Atrophy - Parkinsonian Subtype (MSA-P), Multiple System Atrophy, MSA
- What is being tested?
- Aleeto
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2025to 31 Dec 2026
- Phase
- Early Phase 1
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.30 years ≤ 75 years of age, regardless of sex; 2.Clinically confirmed or clinically probable MSA-P; 3.Poor response to levodopa; 4.MSA-related motor symptom onset ≤5 years at first visit; 5.Walking ≥10 meters independently or with a walking aid; 6.Expected survival of ≥1 year, as determined by the investigator; 7.Signed informed consent.
Who cannot join
- Head MRI at screening showing evidence of other CNS lesions consistent with a diagnosis of neurodegenerative disease other than MSA;
- Patients with MMSE scores indicative of dementia prior to enrolment (≤17 points for illiterate individuals, ≤20 points for individuals with elementary school education, ≤24 points for individuals with junior high school education or higher) or those with a prior confirmed diagnosis of dementia;
- Head MRI at screening showing other significant pathological findings including but not limited to: cerebral hemorrhage, acute phase of cerebral infarction, aneurysm, vascular malformation, infectious lesion, brain tumor or other space-occupying lesion (meningiomas or arachnoid cysts with a maximum diameter of <1 cm need not be excluded);
- Presence of immune disorders that are inadequately controlled or require treatment with biological agents;
- Known history of allergy to biological agents such as proteins and cell products;
- Patients who have received any vaccination within 1 month;
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- Patients with pre-existing, clearly diagnosed malignant tumor or being treated with anti-tumor drugs;
- Patients with a history of clearly diagnosed epilepsy or taking antiepileptic drugs;
- Presence of lumbar spine disease and deformity or other contraindications to lumbar puncture;
- Patients with abnormal coagulation function prior to enrolment (e.g., platelet count <100 × 10E9/L; prothrombin time [PT] >3 s), previous diagnosis of coagulation disorders such as hemophilia, and patients currently receiving more than two types of antiplatelet medication;
- Contraindications to MRI (e.g. claustrophobia, internal placement of pacemakers or paramagnetic metals, etc.);
- With severe hepatic insufficiency, renal insufficiency or severe cardiac insufficiency (severe hepatic insufficiency refers to ALT value≥2.0 times the upper limit of normal value or AST value≥2.0 times the upper limit of normal value; severe renal insufficiency refers to CRE≥1.5 times the upper limit of normal value or eGFR<40mL/min/1.73m2; severe cardiac insufficiency refers to NYHA class 3-4);
- Hepatitis B active infection (hepatitis B surface antigen positive and/or serum HBV DNA positive or serum HBV DNA > 2 × 10E8 IU/ml;
- Hepatitis C virus antibody positive or history of positive test;
- Positive HIV test or history of positive test;
- Patients with a combined history of alcohol or drug abuse or alcohol or drug dependence within 2 years;
- Other psychiatric disorders diagnosed according to DSM-V diagnostic criteria, or significant suicide intent;
- Patients who are pregnant, breast-feeding, or who are likely to become pregnant and plan to become pregnant;
- Patients who are participating in other interventional studies or using other investigational biological agents, drugs, or devices, and patients who have used other experimental drugs within 1 month or within 5 drug half-lives;
- Unable to be cooperative and complete the follow-up due to other reasons.
- Patients who, in the opinion of the investigator, are not suitable for participation in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Yilong Wang, M.D., 010-59976247, yilong528@aliyun.com
About this study
This is a single-center, prospective, randomized, open-label, blinded outcome assessment (PROBE) study. At the end of the PROBE study, patients who have completed the study may opt to enter the open-label extension (OLE) study. The objective of the study is to evaluate the safety, tolerability and potential preliminary efficacy of Aleeto in the treatment of patients with multiple system atrophy (MSA).
Read the detailed description
Multiple system atrophy (MSA) is a progressive neurodegenerative disorder characterized by a blend of autonomic dysfunction, Parkinson's syndrome, and cerebellar syndrome. The incidence of MSA ranges from 1.9 to 4.9 per 100,000 individuals, with an average age of onset of 56.2 years. Among individuals aged 50 years and older, the prevalence stands at 3.0 per 100,000. The mean age of MSA onset is 56.2 years, and the median survival ranges from 6.2 to 7.5 years. Severe autonomic dysfunction manifests early in the disease course, impacting patient survival. The challenges in early diagnosis, rapid disease progression, and bleak prognosis of MSA lead to approximately half of patients needing a walker or assistance from family members for mobility within three years of motor symptom onset. By the fifth year, 60% of patients rely on a wheelchair, and the majority become bedridden within six to eight years. This progression significantly diminishes their quality of life and survival.
Treating MSA, a rare neurodegenerative condition, remains a significant challenge. Current symptomatic and supportive therapies fall short of meeting the treatment requirements of MSA patients. Furthermore, potential adverse effects and disease progression factors restrict the use of certain drugs, highlighting the critical need for the development of disease-modifying or neuroprotective agents to decelerate disease advancement.
"Aleeto, a nerve repair protein created by Darwin Origin (Beijing) Biopharmaceutical Co.LTD, is derived from cellular exosomes, a set of specific microenvironmental protein polymers secreted by stem cells under emergency conditions. It boasts selective assembly, targeted delivery, highly efficient tissue repair, exceptional safety, chemical stability, and convenient storage. Previous basic research has indicated Aleeto's potential for promoting endogenous neural tissue repair, exhibiting significant neuroprotective and neurorestorative effects in animal models. Consequently, this project initiates a single-center, prospective, randomized, open-label, blinded outcome assessment (PROBE) study, followed by an open-label extension (OLE) study. The objectives are to evaluate the safety, tolerability, and potential preliminary efficacy of Aleeto in treating MSA patients and to explore effective MSA treatments.
This study aims to recruit 20 MSA-parkinsonian type (MSA-P) patients aged between 30 and 75 years. The visit content at each stage of this study includes vital signs, neurological examination, laboratory tests (such as routine blood test, blood biochemical examination, coagulation test, etc.), imaging examinations (such as MRI, bladder ultrasound), neurological assessments (such as unified multiple system atrophy rating scale [UMSARS], composite autonomic symptom score [COMPASS], EuroQol Five Dimensions Questionnaire [EQ-5D], Mini-Mental State Examination [MMSE]), and cerebrospinal fluid collection. Different stages of the study focus on monitoring patients' concomitant medications, adverse events, and serious adverse events. Detailed follow-up is conducted at the end of each treatment period, with face-to-face visits at specific time points. Additionally, researchers are required to promptly report and manage events when patients develop new neurological symptoms or suspicious events. The follow-up content of the study includes treatment and follow-up assessments at multiple stages. Initially, comprehensive physical examinations, laboratory tests (including blood, urine, pregnancy tests, etc.), multidimensional scoring assessments (such as UMSARS, COMPASS, EQ-5D, MMSE), and brain examinations through imaging techniques such as 3T MRI are performed on subjects at baseline. Subsequently, subjects enter three treatment periods and follow-up stages lasting a total of 90 days, with daily monitoring of vital signs, cerebrospinal fluid collection, laboratory tests, and adverse event documentation in each stage. Follow-up during the Open-Label Extension (OLE) phase (from day 90 to day 165 post-randomization) continues monitoring of vital signs, laboratory tests, and adverse event recording. At the follow-up visits on day 90, day 180, and day 360, comprehensive physical examinations, laboratory tests, gait analysis, bladder ultrasound, MRI, and repeat UMSARS, COMPASS, EQ-5D scoring are conducted. Additionally, if patients experience new neurological symptoms or suspicious events, additional visits will be carried out, and researchers are required to submit and interpret relevant data within 72 hours of the event occurrence.
The protocol of this study has been approved by the Ethics Committee of Beijing Tiantan Hospital. All participants will provide written informed consents before entering the study.
- Being tested
- Aleeto
- Keywords
- Multiple System Atrophy, Treatment, Exosomes, Neurorepair
- Medical subject headings
- Multiple System Atrophy, Thyroid Dyshormonogenesis 2A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AleetoDrug
"Aleeto" is a nerve repair protein developed by Darwin Start (Beijing) Biopharmaceutical Co., Ltd. It is a group of specific microenvironmental protein polymers secreted under the emergency conditions of stem cells. It has the advantages of selective assembly, targeted delivery, efficient repair of damaged tissues, high safety, chemical stability, easy storage, etc., and has a powerful neural repair function. According to the groups, patients would be treated with Aleeto via intrathecal injection or intravenous injection.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intrathecal administration combined with intravenous administration of Aleeto of Aleeto was given to each MSA patient in the intervention group, with intrathecal administration on days 1, 31 and 61 and intravenous administration on days 2 to 14, 32 to 44±3 and 62 to 74±5, and treatment was given once a day.
intrathecal administration: 8 mL sodium chloride injection + Aleeto (130 μg/branch) for intrathecal administration, which was completed in about 5 minutes; intravenous administration: Aleeto (130 μg/branch) was dissolved in 100 ml sodium chloride injection, which was completed in about 30-40 minutes. After completion of the above treatments and 90±7 days of follow-up, all subjects entered the OLE study phase. During this period, all participants were given the option of continuing to receive 3 phases (on Days 91 to 104±7, Days 121 to 134±7, and Days 151 to 164±7) of intravenous Aleeto administration (14 consecutive days of Aleeto 130 μg qd i.v. in each phase). Receives: Drug: Aleeto |
| Control group | No intervention | Each MSA patient in the blank control group received only basic treatment with no trial-related treatment. After completion of the above treatments and 90±7 days of follow-up, all subjects entered the OLE study phase. During this period, all participants were given the option of continuing to receive 3 phases (on Days 91 to 104±7, Days 121 to 134±7, and Days 151 to 164±7) of intravenous Aleeto administration (14 consecutive days of Aleeto 130 μg qd i.v. in each phase). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of investigator-reported adverse events (AEs) and serious adverse events (SAEs)
Incidence of investigator-reported adverse events (AEs) and serious adverse events (SAEs) within 90±7 days after randomization;
Measured: Day 90±7 after randomization
The incidence of changes in clinical laboratory test parameters, changes in vital signs, neurological examination abnormalities and ECG abnormalities
Laboratory tests include: routine blood test, coagulation test, blood biochemical examination, urinalysis (note that abnormal changes in laboratory test results may need to be reviewed to further determine and assess their relevance to the study). Vital signs include: abnormal body temperature (≥38℃ or ≤35℃), blood pressure (systolic blood pressure ≥180mmHg or <90mmHg), respiration (>24 beats/min and other rhythm abnormalities), heart rate (>100%), and blood pressure (<10%).
Measured: Day 90±7 after randomization
Secondary outcomes (10)
Changes in the unified multiple system atrophy rating scale (UMSARS) part scores, sum of part 1 and 2 scores
The unified multiple system atrophy rating scale (UMSARS) is composed of four subscales: UMSARS-I (12 items) rates patient-reported functional disability, UMSARS-II (14 items) assesses motor impairment based on a clinical examination, UMSARS-III records blood pressure and heart rate in the supine and standing positions, and UMSARS-IV (1 item) rates chore-based disability. Higher scores on the UMSARS indicate greater disability.
Measured: Day 15, 45±3, 75±5 and 90±7 after randomization
Changes in the composite autonomic symptom score (COMPASS) scores
The Composite Autonomic Symptom Score (COMPASS) is a revised version of the 169-item Autonomic Symptom Profile assessing 11 domains of autonomic function, to the 31-item COMPASS, now assessing six domains: orthostatic hypotension (maximum score 10), vasomotor (maximum score 6), secretomotor (maximum score 7), gastrointestinal (maximum score 28), bladder (maximum score 9), and pupillomotor functions (maximum score 15). Scores from each component are recorded and a weighted total score is calculated. Higher scores on this scale indicate more severe clinical symptoms related to autonomic dysfunction. It is a validated, easy-to-use self-assessment instrument designed for clinical autonomic research and practice.
Measured: Day 15, 45±3, 75±5 and 90±7 after randomization
Changes in the incidence of orthostatic hypotension
Changes in the incidence of orthostatic hypotension in patients on days 8, 38±3, 68±5, and 90±7 after randomization as measured by recumbent-upright blood pressure monitoring/24-hour ambulatory blood pressure monitoring/head-upright tilt test;
Measured: Day 15, 45±3, 75±5 and 90±7 after randomization
Variation of three-dimensional gait analysis parameters under multitasking
Changes in three-dimensional gait analysis parameters under multitasking in patients on day 90±7 after randomization;
Measured: Day 90±7 after randomization
EuroQol Five Dimensions Questionnaire (EQ-5D)
The EuroQol Five Dimensions Questionnaire (EQ-5D) consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Measured: Day 90±7 after randomization
Changes in the Berg Balance Scale
The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.
Measured: Day 90±7 after randomization
Changes in the Fatigue Severity Scale (FSS)
The Fatigue Severity Scale (FSS) evaluates impact of fatigue through a short self-report questionnaire consisting in statements that help the patient rate the severity of their fatigue symptoms as related to fatigue impact on their daily activities and lifestyle. The sum of the 9 items is then divided by 9 to obtain the average response value, hence the FSS ranges from 1 to 7. The higher the score, the greater the severity of fatigue and the negative effect on the person's activities.
Measured: Day 90±7 days after randomization
Changes in the Zung Self - Rating Anxiety Scale (SAS)
The Zung Self-Rating Anxiety Scale (SAS) is a psychological assessment tool designed to quantify a person's level of anxiety. It consists of 20 items, each of which is scored on a four-point scale ranging from "none or a little of the time" to "most or all of the time." This self-administered questionnaire is utilized in both clinical and research settings to evaluate the presence and intensity of anxiety symptoms.
Measured: Day 90±7 days after randomization
Changes in the Zung Self-Rating Depression Scale
The Zung Self-Rating Depression Scale was designed by W.W. Zung to assess the level of depression for patients diagnosed with depressive disorder. The Zung Self-Rating Depression Scale is a short self-administered survey to quantify the depressed status of a patient. There are 20 items on the scale that rate the four common characteristics of depression: the pervasive effect, the physiological equivalents, other disturbances, and psychomotor activities. There are ten positively worded and ten negatively worded questions. Each question is scored on a scale of 1-4 (a little of the time, some of the time, good part of the time, most of the time).
Measured: Day 90±7 days after randomization
Changes in immunological indices (lymphocyte subpopulation)
Changes in immunological indices (lymphocyte subpopulation) on days 15, 30±3, 45±3, 60±5, 75±5, 105±7, 135±7, and 165±7 after randomization.
Measured: Day 15, 30±3, 45±3, 60±5, 75±5, 105±7, 135±7, and 165±7 after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start31 May 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple System Atrophy - Parkinsonian Subtype (MSA-P)Studies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yilong Wang, Beijing Tiantan Hospital
- Investigators
- Yilong Wang, M.D., Principal investigator, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaTao Feng, M.D., Principal investigator, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765733
- Sponsor's protocol ID
- KY2024-314-02
- Acronym
- SPRITE
- Status last verified
- Aug 2025
- First submitted
- 26 Nov 2024
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Safety and Preliminary Efficacy of Aleeto in Patients With MultIple System Atrophy
- ClinicalTrials.gov ID
- NCT06765733
- Acronym / sponsor ID
- SPRITE / KY2024-314-02
- Keywords
- Multiple System Atrophy, Treatment, Exosomes, Neurorepair
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 31 May 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Jan 2025 (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.
This is a single-center, prospective, randomized, open-label, blinded outcome assessment (PROBE) study. At the end of the PROBE study, patients who have completed the study may opt to enter the open-label extension (OLE) study. The objective of the study is to evaluate the safety, tolerability and potential preliminary efficacy of Aleeto in the treatment of patients with multiple system atrophy (MSA).
Detailed description
Multiple system atrophy (MSA) is a progressive neurodegenerative disorder characterized by a blend of autonomic dysfunction, Parkinson's syndrome, and cerebellar syndrome. The incidence of MSA ranges from 1.9 to 4.9 per 100,000 individuals, with an average age of onset of 56.2 years. Among individuals aged 50 years and older, the prevalence stands at 3.0 per 100,000. The mean age of MSA onset is 56.2 years, and the median survival ranges from 6.2 to 7.5 years. Severe autonomic dysfunction manifests early in the disease course, impacting patient survival. The challenges in early diagnosis, rapid disease progression, and bleak prognosis of MSA lead to approximately half of patients needing a walker or assistance from family members for mobility within three years of motor symptom onset. By the fifth year, 60% of patients rely on a wheelchair, and the majority become bedridden within six to eight years. This progression significantly diminishes their quality of life and survival.
Treating MSA, a rare neurodegenerative condition, remains a significant challenge. Current symptomatic and supportive therapies fall short of meeting the treatment requirements of MSA patients. Furthermore, potential adverse effects and disease progression factors restrict the use of certain drugs, highlighting the critical need for the development of disease-modifying or neuroprotective agents to decelerate disease advancement.
"Aleeto, a nerve repair protein created by Darwin Origin (Beijing) Biopharmaceutical Co.LTD, is derived from cellular exosomes, a set of specific microenvironmental protein polymers secreted by stem cells under emergency conditions. It boasts selective assembly, targeted delivery, highly efficient tissue repair, exceptional safety, chemical stability, and convenient storage. Previous basic research has indicated Aleeto's potential for promoting endogenous neural tissue repair, exhibiting significant neuroprotective and neurorestorative effects in animal models. Consequently, this project initiates a single-center, prospective, randomized, open-label, blinded outcome assessment (PROBE) study, followed by an open-label extension (OLE) study. The objectives are to evaluate the safety, tolerability, and potential preliminary efficacy of Aleeto in treating MSA patients and to explore effective MSA treatments.
This study aims to recruit 20 MSA-parkinsonian type (MSA-P) patients aged between 30 and 75 years. The visit content at each stage of this study includes vital signs, neurological examination, laboratory tests (such as routine blood test, blood biochemical examination, coagulation test, etc.), imaging examinations (such as MRI, bladder ultrasound), neurological assessments (such as unified multiple system atrophy rating scale [UMSARS], composite autonomic symptom score [COMPASS], EuroQol Five Dimensions Questionnaire [EQ-5D], Mini-Mental State Examination [MMSE]), and cerebrospinal fluid collection. Different stages of the study focus on monitoring patients' concomitant medications, adverse events, and serious adverse events. Detailed follow-up is conducted at the end of each treatment period, with face-to-face visits at specific time points. Additionally, researchers are required to promptly report and manage events when patients develop new neurological symptoms or suspicious events. The follow-up content of the study includes treatment and follow-up assessments at multiple stages. Initially, comprehensive physical examinations, laboratory tests (including blood, urine, pregnancy tests, etc.), multidimensional scoring assessments (such as UMSARS, COMPASS, EQ-5D, MMSE), and brain examinations through imaging techniques such as 3T MRI are performed on subjects at baseline. Subsequently, subjects enter three treatment periods and follow-up stages lasting a total of 90 days, with daily monitoring of vital signs, cerebrospinal fluid collection, laboratory tests, and adverse event documentation in each stage. Follow-up during the Open-Label Extension (OLE) phase (from day 90 to day 165 post-randomization) continues monitoring of vital signs, laboratory tests, and adverse event recording. At the follow-up visits on day 90, day 180, and day 360, comprehensive physical examinations, laboratory tests, gait analysis, bladder ultrasound, MRI, and repeat UMSARS, COMPASS, EQ-5D scoring are conducted. Additionally, if patients experience new neurological symptoms or suspicious events, additional visits will be carried out, and researchers are required to submit and interpret relevant data within 72 hours of the event occurrence.
The protocol of this study has been approved by the Ethics Committee of Beijing Tiantan Hospital. All participants will provide written informed consents before entering the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: AleetoIntrathecal administration combined with intravenous administration of Aleeto of Aleeto was given to each MSA patient in the intervention group, with intrathecal administration on days 1, 31 and 61 and intravenous administration on days 2 to 14, 32 to 44±3 and 62 to 74±5, and treatment was given once a day. intrathecal administration: 8 mL sodium chloride injection + Aleeto (130 μg/branch) for intrathecal administration, which was completed in about 5 minutes; intravenous administration: Aleeto (130 μg/branch) was dissolved in 100 ml sodium chloride injection, which was completed in about 30-40 minutes. After completion of the above treatments and 90±7 days of follow-up, all subjects entered the OLE study phase. During this period, all participants were given the option of continuing to receive 3 phases (on Days 91 to 104±7, Days 121 to 134±7, and Days 151 to 164±7) of intravenous Aleeto administration (14 consecutive days of Aleeto 130 μg qd i.v. in each phase). |
| Control group | No intervention | –Each MSA patient in the blank control group received only basic treatment with no trial-related treatment. After completion of the above treatments and 90±7 days of follow-up, all subjects entered the OLE study phase. During this period, all participants were given the option of continuing to receive 3 phases (on Days 91 to 104±7, Days 121 to 134±7, and Days 151 to 164±7) of intravenous Aleeto administration (14 consecutive days of Aleeto 130 μg qd i.v. in each phase). |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.30 years ≤ 75 years of age, regardless of sex; 2.Clinically confirmed or clinically probable MSA-P; 3.Poor response to levodopa; 4.MSA-related motor symptom onset ≤5 years at first visit; 5.Walking ≥10 meters independently or with a walking aid; 6.Expected survival of ≥1 year, as determined by the investigator; 7.Signed informed consent.
Key exclusion criteria (21 listed)
- Head MRI at screening showing evidence of other CNS lesions consistent with a diagnosis of neurodegenerative disease other than MSA;
- Patients with MMSE scores indicative of dementia prior to enrolment (≤17 points for illiterate individuals, ≤20 points for individuals with elementary school education, ≤24 points for individuals with junior high school education or higher) or those with a prior confirmed diagnosis of dementia;
- Head MRI at screening showing other significant pathological findings including but not limited to: cerebral hemorrhage, acute phase of cerebral infarction, aneurysm, vascular malformation, infectious lesion, brain tumor or other space-occupying lesion (meningiomas or arachnoid cysts with a maximum diameter of <1 cm need not be excluded);
- Presence of immune disorders that are inadequately controlled or require treatment with biological agents;
- Known history of allergy to biological agents such as proteins and cell products;
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 |
|---|---|---|
| Aleeto"Aleeto" is a nerve repair protein developed by Darwin Start (Beijing) Biopharmaceutical Co., Ltd. It is a group of specific microenvironmental protein polymers secreted under the emergency conditions of stem cells. It has the advantages of selective assembly, targeted delivery, efficient repair of damaged tissues, high safety, chemical stability, easy storage, etc., and has a powerful neural repair function. According to the groups, patients would be treated with Aleeto via intrathecal injection or intravenous injection. | Drug | Intervention group |
Primary outcome
The incidence of investigator-reported adverse events (AEs) and serious adverse events (SAEs)
Time frame: Day 90±7 after randomization
Incidence of investigator-reported adverse events (AEs) and serious adverse events (SAEs) within 90±7 days after randomization;
The incidence of changes in clinical laboratory test parameters, changes in vital signs, neurological examination abnormalities and ECG abnormalities
Time frame: Day 90±7 after randomization
Laboratory tests include: routine blood test, coagulation test, blood biochemical examination, urinalysis (note that abnormal changes in laboratory test results may need to be reviewed to further determine and assess their relevance to the study). Vital signs include: abnormal body temperature (≥38℃ or ≤35℃), blood pressure (systolic blood pressure ≥180mmHg or <90mmHg), respiration (>24 beats/min and other rhythm abnormalities), heart rate (>100%), and blood pressure (<10%).
10 secondary outcomes
Changes in the unified multiple system atrophy rating scale (UMSARS) part scores, sum of part 1 and 2 scores
Time frame: Day 15, 45±3, 75±5 and 90±7 after randomization
Changes in the composite autonomic symptom score (COMPASS) scores
Time frame: Day 15, 45±3, 75±5 and 90±7 after randomization
Changes in the incidence of orthostatic hypotension
Time frame: Day 15, 45±3, 75±5 and 90±7 after randomization
Variation of three-dimensional gait analysis parameters under multitasking
Time frame: Day 90±7 after randomization
EuroQol Five Dimensions Questionnaire (EQ-5D)
Time frame: Day 90±7 after randomization
Changes in the Berg Balance Scale
Time frame: Day 90±7 after randomization
Changes in the Fatigue Severity Scale (FSS)
Time frame: Day 90±7 days after randomization
Changes in the Zung Self - Rating Anxiety Scale (SAS)
Time frame: Day 90±7 days after randomization
Changes in the Zung Self-Rating Depression Scale
Time frame: Day 90±7 days after randomization
Changes in immunological indices (lymphocyte subpopulation)
Time frame: Day 15, 30±3, 45±3, 60±5, 75±5, 105±7, 135±7, and 165±7 after randomization
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 3 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Yilong Wang, M.D. principal investigator
Beijing Tiantan Hospital, Capital Medical University, Beijing, China
Tao Feng, M.D. principal investigator
Beijing Tiantan Hospital, Capital Medical University, Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Aleeto in people with Multiple System Atrophy - Parkinsonian Subtype (MSA-P) and Multiple System Atrophy, MSA, run by Beijing Tiantan Hospital 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 1 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 3 Sep 2025. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Weiqi Chen, M.D. (8615652813380, weiqichen@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of investigator-reported adverse events (AEs) and serious adverse events (SAEs) (time frame: Day 90±7 after randomization). The study lists 2 primary outcomes in all. 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 3 Sep 2025.