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Bone Marrow Derived Stem Cells Mobilization for Treatment of Abnormal Endometrium

NCT05343572 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-11-12

No results posted yet for this study

Summary

This study will assess the use of autologous bone marrow stem cells mobilization using 1,1'-\[1,4-phenylenebis-(methylene)\]-bis-1,4,8,11-tetraazacyclotetradecane (PLERIXAFOR) as an effective medical therapy for the treatment of Asherman's Syndrome (AS), Atrophic Endometrium (AE) and Recurrent Implantation Failure (RIF).

Conditions

  • Asherman Syndrome
  • Atrophic Endometrium
  • Recurrent Implantation Failure

Interventions

DRUG

Plerixafor

A 20mg single dose of PLERIXAFOR is administered subcutaneously the evening prior to scheduled standard of care surgery for women with AS, AE or RIF for peripheral mobilization of stem cells. For subjects weighing \>83 kilogram, the dosing is a single dose of 0.24 milligram per kilogram.

Sponsors & Collaborators

  • Hugh Taylor

    lead OTHER

Principal Investigators

  • Hugh Taylor, MD · Yale University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05343572 on ClinicalTrials.gov