Allogeneic Wharton Jelly Mesenchymal Stromal Cell (WJMSC) for Treatment of Autism

Autism Clinical Trial

Official title:

Allogeneic Wharton Jelly Mesenchymal Stromal Cell (WJMSC) for Treatment of Autism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06293950
• Other study ID #: AUTISM
• Status: Recruiting
• Phase: Phase 1
• Start date: March 9, 2022
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: University of Jordan
• Contact: Hanan Jafar, PhD
• Phone: 00962798871087
• Email: hanan.jafar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 14 Years

Eligibility

Inclusion Criteria:

• 14 subjects, 4-14 years of age, will be enrolled into this study, who meet the criteria for (ASD

Exclusion Criteria:

• 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.

• 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.

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

Biological:
• WJMSC
- Patients receive three intravenous doses of MSCs (1 million/kg) every two weeks as treatment.

Locations

Country	Name	City	State
Jordan	Cell Therapy Center	Amman

Sponsors (1)

Lead Sponsor	Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety profile lab tests	-patients will be monitored for any possible adverse events resulting from the injection of MSCs.	follow-up duration is 12 months
Secondary	efficacy change in Adult ADHD Self-Report Scale (ASRS)	-The subjects will be monitored with ASRS at baseline, 3, 6, 9, and 12 months	follow-up duration is 12 months