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

NCT ID: NCT06293950

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-09
• Study Completion Date: 2027-12-31

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

WJMSC

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

Group Type: EXPERIMENTAL

WJMSC

Intervention Type: BIOLOGICAL

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

Interventions

WJMSC

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Jordan

OTHER

Sponsor Role: lead

Responsible Party

Hanan Jafar

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abdallah Awidi, MD

Role: STUDY_DIRECTOR

Cell Therapy Center

Locations

Cell Therapy Center

Amman, , Jordan

Site Status: RECRUITING

Countries

Jordan

Central Contacts

Hanan Jafar, PhD

Role: CONTACT

hanan.jafar@gmail.com

00962798871087

Abdallah Awidi, MD

Role: CONTACT

abdalla.awidi@gmail.com

0096265355000 ext. 23960

Facility Contacts

Hanan Jafar, PhD

Role: primary

hanan.jafar@gmail.com

00962798871087

Abdallah Awidi, MD

Role: backup

abdalla.awidi@gmail.com

0096265355000 ext. 23960

Other Identifiers

AUTISM

Identifier Type: -

Identifier Source: org_study_id