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Safety & Efficacy of AlloRx SC® in PTHS Patients

NCT05165017 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2021-12-21

No results posted yet for this study

Summary

This study will evaluate the safety of AlloRx Stem Cells® in subjects with Pitt Hopkins syndrome ages 2-45 with a molecularly confirmed pathogenic mutation in TCF4 or 18q deletion including TCF4. Participants will receive mesenchymal stem cells infusions every 3 months for a year with completion of outcome measures to assess the efficacy of the product.

Conditions

  • Pitt Hopkins Syndrome

Interventions

BIOLOGICAL

AlloRx Stem Cells®

Umbilical cord-derived allogeneic mesenchymal stem cells

OTHER

Placebo control

Placebo infusion without mesenchymal stem cells

Sponsors & Collaborators

  • Vitro Biopharma Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-31
Primary Completion
2022-12-31
Completion
2023-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05165017 on ClinicalTrials.gov