AutismPhase 1NCT06293950
Allogeneic Wharton Jelly Mesenchymal Stromal Cell (WJMSC) for Treatment of Autism
A Phase 1 study testing WJMSC in people with Autism, run by University of Jordan at 1 site in Jordan.
Trial summary
Autism spectrum disorders (ASDs) are characterized by core domains: persistent deficits in social communication and interaction; restricted, repetitive patterns of behavior, interests, or activities. Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Autism
- What is being tested?
- WJMSC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteJordan
- Study dates
- 9 Mar 2022to Dec 2027
- 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 4 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 14 subjects, 4-14 years of age, will be enrolled into this study, who meet the criteria for (ASD
Who cannot join
- Age > 14 years.
- Patient weighing < 10 kg.
- History of severe Allergy
- History of severe head trauma, defined by loss of consciousness or hospitalization, skull fracture, or stroke.
- Seizure within the last year before enrollment, or the need for seizure medications either at present or in the past.
- Evidence or history of severe, moderate, or uncontrolled systemic disease.
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- Inability to follow the prescribed dosing and follow-up schedule.
- Use of any stimulant or non-stimulant medication or medications given for attention deficit hyperactivity disorder (ADHD) must be discontinued 7 days before the initial randomized study period.
- Subjects taking a selective serotonin reuptake inhibitor (SSRI) must be on a stable dose for a minimum of 30 days before entering the study.
- History of premature birth <35 weeks' gestation.
- Prior history of stroke in utero or other in utero insult.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jordan1 site, 1 recruiting
- Recruiting
Cell Therapy Center
Amman, 00962
Hanan Jafar, PhD, 00962798871087, hanan.jafar@gmail.com
Abdallah Awidi, MD, 0096265355000 ext. 23960, abdalla.awidi@gmail.com
About this study
Autism spectrum disorders (ASDs) are characterized by core domains: persistent deficits in social communication and interaction; restricted, repetitive patterns of behavior, interests, or activities.
Read the detailed description
Autism spectrum disorders (ASDs) are characterized by core domains: persistent deficits in social communication and interaction; restricted, repetitive patterns of behavior, interests, or activities. ASDs comprise heterogeneous and complex neuro-developmental pathologies with well-defined inflammatory conditions and immune system dysfunction. Due to neurobiological changes underlying ASD development, cell-based therapies have been proposed and applied to ASDs. Indeed, stem cells show specific immunologic properties, which make them promising candidates for ASD treatment.
- Conditions
- Autism
- Being tested
- WJMSC
- Keywords
- autism, WJMSC
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WJMSCBiological
- Patients receive three intravenous doses of MSCs (1 million/kg) every two weeks as treatment.
| Study group | Role | What they receive |
|---|---|---|
| WJMSC | Experimental | - Patients receive three intravenous doses of MSCs (1 million/kg) every two weeks as treatment. Receives: Biological: WJMSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety profile lab tests
-patients will be monitored for any possible adverse events resulting from the injection of MSCs.
Measured: follow-up duration is 12 months
Secondary outcomes (1)
efficacy change in Adult ADHD Self-Report Scale (ASRS)
-The subjects will be monitored with ASRS at baseline, 3, 6, 9, and 12 months
Measured: follow-up duration is 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start9 Mar 2022
- Primary completionJun 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanan Jafar, University of Jordan
- Investigators
- Abdallah Awidi, MD, Study director, Cell Therapy Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293950
- Sponsor's protocol ID
- AUTISM
- Status last verified
- Jan 2025
- First submitted
- 9 May 2023
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Wharton Jelly Mesenchymal Stromal Cell (WJMSC) for Treatment of Autism
- ClinicalTrials.gov ID
- NCT06293950
- Acronym / sponsor ID
- AUTISM
- Conditions
- Autism
- Keywords
- autism, WJMSC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Autism spectrum disorders (ASDs) are characterized by core domains: persistent deficits in social communication and interaction; restricted, repetitive patterns of behavior, interests, or activities.
Detailed description
Autism spectrum disorders (ASDs) are characterized by core domains: persistent deficits in social communication and interaction; restricted, repetitive patterns of behavior, interests, or activities. ASDs comprise heterogeneous and complex neuro-developmental pathologies with well-defined inflammatory conditions and immune system dysfunction. Due to neurobiological changes underlying ASD development, cell-based therapies have been proposed and applied to ASDs. Indeed, stem cells show specific immunologic properties, which make them promising candidates for ASD treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WJMSC | Experimental | Biological: WJMSC- Patients receive three intravenous doses of MSCs (1 million/kg) every two weeks as treatment. |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 14 subjects, 4-14 years of age, will be enrolled into this study, who meet the criteria for (ASD
Key exclusion criteria (11 listed)
- Age > 14 years.
- Patient weighing < 10 kg.
- History of severe Allergy
- History of severe head trauma, defined by loss of consciousness or hospitalization, skull fracture, or stroke.
- Seizure within the last year before enrollment, or the need for seizure medications either at present or in the past.
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 |
|---|---|---|
| WJMSC- Patients receive three intravenous doses of MSCs (1 million/kg) every two weeks as treatment. | Biological | WJMSC |
Primary outcome
safety profile lab tests
Time frame: follow-up duration is 12 months
-patients will be monitored for any possible adverse events resulting from the injection of MSCs.
1 secondary outcome
efficacy change in Adult ADHD Self-Report Scale (ASRS)
Time frame: follow-up duration is 12 months
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 24 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Abdallah Awidi, MD study director
Cell Therapy Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing WJMSC in people with Autism, run by University of Jordan at 1 site in Jordan.
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 11 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 24 Jan 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 Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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 Hanan Jafar, PhD (00962798871087, hanan.jafar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety profile lab tests (time frame: follow-up duration is 12 months). 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 24 Jan 2025.