Autism Spectrum DisorderPhase 1ASDNCT07177677
A Study of Mesenchymal Stem Cell in the Treatment of Autism Spectrum Disorder
A Phase 1 study testing hBMMSC in people with Autism Spectrum Disorder, run by Jiuzhitang Maker (Beijing) Cell Technology Co.,Ltd..
Trial summary
This clinical trial aims to evaluate the safety and preliminary efficacy of intravenous administration of human bone marrow-derived mesenchymal stem cells (hBMMSCs) in patients with autism spectrum disorder (ASD). Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- hBMMSC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2025to 30 Aug 2028
- Phase
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female ≥6 years old
- Body weight ≥ 17 kg
- Meets the diagnostic criteria for Autism Spectrum Disorder (ASD) as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), and confirmed by the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule-2 (ADOS-2)
- Has either not received any psychotropic medication in the three months prior to enrollment or has been on a stable regimen of psychotropic medication for at least three months
- The subject and/or their legal guardian(s) agree to participate in the trial and provide signed informed consent.
Who cannot join
- Inability of the subject or their guardian to sufficiently understand instructions in Chinese
- Active infection (viral, bacterial, fungal, or mycobacterial)
- A confirmed diagnosis of Rett syndrome, childhood disintegrative disorder, fragile X syndrome, or other genetic/metabolic diseases that may impact cognitive development
- History of epileptic seizures within 6 months prior to enrollment
- History of suicide attempts/self-harm, presentation of suicidal ideation, or being judged as the risk of suicidal by the investigator
- Severe hematologic diseases or active malignancy
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- Severe hepatic or renal disease
- Participation in a drug clinical trial within 3 months prior to enrollment (unless beyond the protocol-defined wash-out period) or participation in any other stem cell study within the past year
- A positive skin test result
- Any other condition which, in the opinion of the investigator, would make the subject unsuitable for participation in this study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Intravenous Injection of Human Bone Marrow Mesenchymal Stem Cell (hBMMSC) in the Treatment of Autism Spectrum Disorder (ASD): An Exploratory Study on the Safety and Preliminary Efficacy
This clinical trial aims to evaluate the safety and preliminary efficacy of intravenous administration of human bone marrow-derived mesenchymal stem cells (hBMMSCs) in patients with autism spectrum disorder (ASD).
Read the detailed description
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized primarily by impaired social communication, restricted interests, and repetitive, stereotyped behaviors. Currently, there are no effective therapeutic drugs, and main interventions consist of educational rehabilitation and behavioral management.The purpose of this study is to evaluate the safety and preliminary efficacy of hBMMSC intravenous treatment in patients with ASD. The clinical trial intends to involve 42 participants. The trial is expected to last approximately 2 years.
- Conditions
- Autism Spectrum Disorder
- Being tested
- hBMMSC
- Keywords
- human Bone Marrow Mesenchymal Stem Cell (hBMMSC), Autism Spectrum Disorder (ASD)
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hBMMSCBiological
Also called human Bone Marrow Mesenchymal Stem Cell
Group 1: 0.5×10^6 cells/kg (participant's body weight) single dose; Group 2: 1.0×10^6 cells/kg (participant's body weight) single dose; Group 3: 2.0×10^6 cells/kg (participant's body weight) single dose.
| Study group | Role | What they receive |
|---|---|---|
| hBMMSC 0.5×10^6 cells/kg | Experimental | human Bone Marrow Mesenchymal Stem Cell (hBMMSC) 0.5×10^6 cells/kg、 1.0×10^6 cells/kg、 2.0×10^6 cells/kg Receives: Biological: hBMMSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Evaluation of hBMMSC Injection in ASD Patients
Adverse events and serious adverse events.
Measured: 48 weeks
Secondary outcomes (1)
Preliminary Efficacy Evaluation of hBMMSC Injection for Patients with ASD
Changes in the scores of the Adaptive Behavior Assessment System (ABAS), Autism Behavior Checklist (ABC), Clinical Global Impression (CGI), Autism Treatment Evaluation Checklist (ATEC), Social Responsiveness Scale(SRS), Repetitive Behavior Scale-Revised (RBS-R), as well as the levels of blood inflammatory factors.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start30 Sep 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiuzhitang Maker (Beijing) Cell Technology Co.,Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- Capital Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07177677
- Sponsor's protocol ID
- MKMSC-CT-003-1
- Acronym
- ASD
- Status last verified
- Sep 2025
- First submitted
- 2 Sep 2025
- Last updated
- 17 Sep 2025
- 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 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Injection of Human Bone Marrow Mesenchymal Stem Cell (hBMMSC) in the Treatment of Autism Spectrum Disorder (ASD): An Exploratory Study on the Safety and Preliminary Efficacy
- ClinicalTrials.gov ID
- NCT07177677
- Acronym / sponsor ID
- ASD / MKMSC-CT-003-1
- Conditions
- Autism Spectrum Disorder
- Keywords
- human Bone Marrow Mesenchymal Stem Cell (hBMMSC), Autism Spectrum Disorder (ASD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Jiuzhitang Maker (Beijing) Cell Technology Co.,Ltd.University, hospital or other
- Collaborators
- Capital Medical University
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 17 Sep 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 clinical trial aims to evaluate the safety and preliminary efficacy of intravenous administration of human bone marrow-derived mesenchymal stem cells (hBMMSCs) in patients with autism spectrum disorder (ASD).
Detailed description
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized primarily by impaired social communication, restricted interests, and repetitive, stereotyped behaviors. Currently, there are no effective therapeutic drugs, and main interventions consist of educational rehabilitation and behavioral management.The purpose of this study is to evaluate the safety and preliminary efficacy of hBMMSC intravenous treatment in patients with ASD. The clinical trial intends to involve 42 participants. The trial is expected to last approximately 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hBMMSC 0.5×10^6 cells/kg | Experimental | Biological: hBMMSChuman Bone Marrow Mesenchymal Stem Cell (hBMMSC) 0.5×10^6 cells/kg、 1.0×10^6 cells/kg、 2.0×10^6 cells/kg |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female ≥6 years old
- Body weight ≥ 17 kg
- Meets the diagnostic criteria for Autism Spectrum Disorder (ASD) as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), and confirmed by the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule-2 (ADOS-2)
- Has either not received any psychotropic medication in the three months prior to enrollment or has been on a stable regimen of psychotropic medication for at least three months
- The subject and/or their legal guardian(s) agree to participate in the trial and provide signed informed consent.
Key exclusion criteria (10 listed)
- Inability of the subject or their guardian to sufficiently understand instructions in Chinese
- Active infection (viral, bacterial, fungal, or mycobacterial)
- A confirmed diagnosis of Rett syndrome, childhood disintegrative disorder, fragile X syndrome, or other genetic/metabolic diseases that may impact cognitive development
- History of epileptic seizures within 6 months prior to enrollment
- History of suicide attempts/self-harm, presentation of suicidal ideation, or being judged as the risk of suicidal by the investigator
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 |
|---|---|---|
| hBMMSCAlso: human Bone Marrow Mesenchymal Stem CellGroup 1: 0.5×10^6 cells/kg (participant's body weight) single dose; Group 2: 1.0×10^6 cells/kg (participant's body weight) single dose; Group 3: 2.0×10^6 cells/kg (participant's body weight) single dose. | Biological | hBMMSC 0.5×10^6 cells/kg |
Primary outcome
Safety Evaluation of hBMMSC Injection in ASD Patients
Time frame: 48 weeks
Adverse events and serious adverse events.
1 secondary outcome
Preliminary Efficacy Evaluation of hBMMSC Injection for Patients with ASD
Time frame: 48 weeks
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 17 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing hBMMSC in people with Autism Spectrum Disorder, run by Jiuzhitang Maker (Beijing) Cell Technology Co.,Ltd..
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 5 inclusion and 10 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 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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 yuan chen (86-4000918989, ychen@jztmaker.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Evaluation of hBMMSC Injection in ASD Patients (time frame: 48 weeks). 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 17 Sep 2025.