Bone Marrow Derived Stem Cells Mobilization for Treatment of Abnormal Endometrium

• Status: Not yet recruiting
• Trial end date: 2026-04-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hugh Taylor
• Treatments: Plerixafor

Criteria

Inclusion Criteria:

• Healthy, non pregnant females

• ages ≥18 and ≤40 years old at time of enrollment

• with either AS, AE, or RIF

1. For AS: surgical history of intrauterine trauma/infection, hypo/amenorrhea, intra-uterine adhesions

2. for AE: US documentation of persistent, <6mm endometrial thickness

3. for RIF: failure to achieve a clinical pregnancy after transfer of at least four good-quality embryos in a minimum of three fresh or frozen cycles in a woman under 40 years and currently being treated at Yale Fertility Clinic

Exclusion Criteria:

• Presence of hydrosalpinx (diagnosed by radiographic or ultrasound imaging)

• Endometriosis (diagnosed by previous surgery,)

• Diminished ovarian reserve (AMH<1ng/ml or follicle stimulating hormone (FSH)>10)

• History of genital tuberculosis or any ultrasound evidence of congenital uterine anomaly

• Submucous or intracavitary fibroid, polyps

• Currently pregnant

• Personal history of thrombophilia or sickle cell disease

• Inability to provide informed consent