Bone Marrow Derived Stem Cells Mobilization for Treatment of Asherman's Syndrome, Atrophic Endometrium, and Recurrent Implantation Failure
Hugh Taylor
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).
Description
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). Primary Objective: * To compare endometrial thickness and implantation rates in women with AS, AE, and RIF receiving PLERIXAFOR compared to historic controls that received existing standard of care therapy * To compare ongoing pregnancy and live birth rates in women with AS,…
Eligibility
- Age range
- 18–40 years
- Sex
- Female
- Healthy volunteers
- Yes
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 (diagnos…
Interventions
- DrugPlerixafor
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.
Location
- Yale Fertility CenterOrange, Connecticut