Allogeneic Wharton Jelly Mesenchymal Stromal Cell (WJMSC) for Treatment of Autism
ConditionAutism
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age4-14
SponsorUniversity of Jordan
About this trial
Autism spectrum disorders (ASDs) are characterized by core domains: persistent deficits in social communication and interaction; restricted, repetitive patterns of behavior, interests, or activities.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
14 subjects, 4-14 years of age, will be enrolled into this study, who meet the criteria for (ASD
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
WJMSC
Biological/Vaccine\- Patients receive three intravenous doses of MSCs (1 million/kg) every two weeks as treatment.
Treatment groups
14 Participants
are divided into 1 treatment groupGroup A: WJMSCExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
safety profile lab tests
-patients will be monitored for any possible adverse events resulting from the injection of MSCs.
Time frame
follow-up duration is 12 monthsSecondary 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
Time frame
follow-up duration is 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov