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

January 23, 2025 updated by: Hanan Jafar, University of Jordan
Autism spectrum disorders (ASDs) are characterized by core domains: persistent deficits in social communication and interaction; restricted, repetitive patterns of behavior, interests, or activities.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WJMSC
- Patients receive three intravenous doses of MSCs (1 million/kg) every two weeks as treatment.
Biological: WJMSC
- Patients receive three intravenous doses of MSCs (1 million/kg) every two weeks as treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
follow-up duration is 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
efficacy change in Adult ADHD Self-Report Scale (ASRS)
Time Frame: follow-up duration is 12 months
-The subjects will be monitored with ASRS at baseline, 3, 6, 9, and 12 months
follow-up duration is 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jordan

Investigators

  • Study Director: Abdallah Awidi, MD, Cell Therapy Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2022

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

May 9, 2023

First Submitted That Met QC Criteria

February 27, 2024

First Posted (Actual)

March 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 23, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUTISM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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