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Mesenchymal Stromal Cells

hCT-MSC for Autism Spectrum Disorder (IMPACT Trial)

Phase 2
Waitlist Available
Led By Lauren Franz, MBChB
Research Sponsored by Joanne Kurtzberg, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months, 12 months
Awards & highlights

IMPACT Trial Summary

This trial will test if hCT-MSC can improve social communication abilities in children with ASD.

Who is the study for?
This trial is for children aged 4 to less than 12 years with Autism Spectrum Disorder (ASD), who have a normal immune cell count, no genetic conditions linked to ASD, and are stable on current psychiatric medications. They must be English-speaking and able to visit Duke University twice. Children with known genetic syndromes, metabolic disorders, significant sensory or motor impairments, or unstable medical conditions cannot participate.Check my eligibility
What is being tested?
The study tests the effectiveness of human umbilical cord tissue-derived mesenchymal stromal cells (hCT-MSC) versus a placebo in improving social communication skills in children with ASD. It's a Phase II trial where participants will receive either the hCT-MSC treatment or a placebo infusion.See study design
What are the potential side effects?
While specific side effects for hCT-MSC are not detailed here, similar treatments may cause reactions at the infusion site, fever, headaches, fatigue or allergic responses. Close monitoring during and after treatment helps manage any potential side effects.

IMPACT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months, 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change on the Socialization and Communication Subscale Standard Scores on the Vineland Behavior Scales
Secondary outcome measures
CGI-Intervention score
Change in CGI-Severity score
Change in VABS-3 Communication Standard Score
+2 more
Other outcome measures
Evidence of formation of anti-HLA antibodies
Incidence and severity of graft versus host disease
Incidence and severity of infusion reactions
+2 more

IMPACT Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MSCExperimental Treatment1 Intervention
One dose of 6x10e6 cells/kg administered intravenously.
Group II: Placebo InfusionPlacebo Group1 Intervention
Placebo infusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cord Tissue Mesenchymal Stromal Cells
2020
Completed Phase 2
~140

Find a Location

Who is running the clinical trial?

The Marcus FoundationOTHER
15 Previous Clinical Trials
1,363 Total Patients Enrolled
4 Trials studying Autism Spectrum Disorder
60 Patients Enrolled for Autism Spectrum Disorder
Cryo-Cell InternationalUNKNOWN
Joanne Kurtzberg, MDLead Sponsor
18 Previous Clinical Trials
579 Total Patients Enrolled
3 Trials studying Autism Spectrum Disorder
203 Patients Enrolled for Autism Spectrum Disorder

Media Library

Cord Tissue Mesenchymal Stromal Cells (Mesenchymal Stromal Cells) Clinical Trial Eligibility Overview. Trial Name: NCT04089579 — Phase 2
Autism Spectrum Disorder Research Study Groups: Placebo Infusion, MSC
Autism Spectrum Disorder Clinical Trial 2023: Cord Tissue Mesenchymal Stromal Cells Highlights & Side Effects. Trial Name: NCT04089579 — Phase 2
Cord Tissue Mesenchymal Stromal Cells (Mesenchymal Stromal Cells) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04089579 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is my eligibility sufficient to join this clinical experiment?

"This research seeks 164 participants, aged 4 to 11 years old, who possess a diagnosis of Autism Spectrum Disorder. In addition to this requirement, potential subjects must be able to attend two visits at Duke University (at baseline and six month intervals), their parent or guardian has the capacity for participating in interim surveys/interviews and provides consent from one parental figure."

Answered by AI

How many individuals are eligible to take part in this trial?

"Currently, this clinical trial is not enrolling participants. It was posted on October 12th 2020 and last updated on October 26th 2022. If you are in search of other trials for comparison purposes, 1137 studies recruiting patients with autism spectrum disorder and 33 related to Cord Tissue Mesenchymal Stromal Cells are actively seeking enrolment."

Answered by AI

Does this research trial accept participants aged 20 and above?

"According to the official study criteria, only individuals aged 4-11 may take part in this medical research."

Answered by AI

How reliable are the therapeutic outcomes of Cord Tissue Mesenchymal Stromal Cells?

"Cord Tissue Mesenchymal Stromal Cells is considered relatively safe, given that this Phase 2 trial has generated supporting evidence of security but not yet efficacy. Consequently, it received a rating of 2 on the scale from 1 to 3."

Answered by AI

Is it currently feasible to enroll in this experiment?

"This particular study is no longer accepting volunteers. It was first made available on October 12th 2020 and the last update to the trial design occurred on October 26th 2022. Alternatively, 1137 trials for Autism Spectrum Disorder are actively recruiting participants, as well as 33 studies concerning Cord Tissue Mesenchymal Stromal Cells that need patients too."

Answered by AI

Who else is applying?

What state do they live in?
Idaho
Michigan
Other
Florida
How old are they?
18 - 65
< 18
What site did they apply to?
Duke University Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Most responsive sites:
  1. Duke University Medical Center: < 24 hours
Average response time
  • < 2 Days
Typically responds via
Email
~31 spots leftby Mar 2025