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NCT07546942

Autism Spectrum Disorder (ASD) Neurodevelopmental Disorder With Issues Social Behavior, Communication Issues, GI Dysfunction. Study is Multimodal Interventions Targeting These Pathways With cSVF, Stored MSCs, FMT and Diet Modification. Role of Autoimmunity, Gut-brain Issues, & Issues Examined.

Enrolling by Invitation
PHASE1Ages 10–90InterventionalTreatment
Black Tie Medical, Inc.
~50 participants
Updated 2026-04-27 on ClinicalTrials.gov
What's tested:Autologous MSC isolation, concentration, and cryopreservation of adult mesenchymal stem cellsFecal Biomicrome Transplantation (FMT)Ketogenic RESET Diet ProtocolTrial combines use of cSVF and MSCs (cryopres) with diet modification and FMT (fecal material Transplant in adult ASD patientsFMT (Fecal Material Tranplantation)Use autologous cSVF + MSCs (cryo) for management of autoimmune component, anti-inflammatory and immune modulation

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Socialization Alterations
Measured over 1 year
+1 more outcome measured

Conditions

Autism Spectrum Disorder
Autism
Autism Spectral Disorder

Explore related trials

Autism Spectrum Disorder

Where it's being run

2 sites across 1 states
Montana2

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

ADS
Stable on current medications or therapy
With/wthout comorbid GI (gut/Axis) symptoms

Exclusion

Recent antiobiotics or probiotic therapy within 30 days
Severe GI disease or malnutrition
Recent major surgery that may interfere with study course
Other Med/Surgery issues that may preclude treatment with this protocol
Inability to perform the monitoring of FMT without supervision by qualfied Provider

What this trial measures

  • Socialization Alterations1 year

    SRS-2 caregiver/teacher: Change in social behavior as measured by the Social Responsiveness Scale, Second Edition (SRS-2), a 65-item caregiver- and teacher-reported instrument scored on a scale of 0 to 195, where lower scores indicate better social functioning. SRS-2 assessments are completed at baseline, 3 months, 6 months, and 12 months to evaluate change over time.Time Frame: Baseline, 3 months, 6 months, and 12 months

  • Communication/Education EnhancementMonths and 1 year

    PPVT-5 Peabody Picture Vocabulary testing: Change in receptive vocabulary and language comprehension as measured by the Peabody Picture Vocabulary Test, Fifth Edition (PPVT-5). Standard scores range from approximately 40 to 160 (mean = 100, SD = 15), where higher scores indicate better vocabulary and language ability. Testing is administered at baseline, 3 months, 6 months, and 12 months.Time Frame: Baseline, 3 months, 6 months, and 12 months