Recruiting
Early Phase 1

Bone Marrow Derived Stem Cells

Sponsor:

Hugh Taylor

Code:

NCT05343572

Conditions

Asherman Syndrome

Atrophic Endometrium

Recurrent Implantation Failure

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Plerixafor

Study Details

Brief 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

Study ID

NCT05343572

Start date

Nov 1, 2023

Status verified date

Nov, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Accepted

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

Study Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Endometrial Disorders

Three groups of patients, with 10 subjects per group:

1. Asherman's syndrome, as classified by the American Society of Reproductive Medicine (ASRM) by extent of uterine cavity involvement and adhesion type. Specifically, refractory Asherman's syndrome: patients who have had at least one operative hysteroscopy which was unsuccessful.
2. Atrophic endometrium, as defined by maximal endometrial lining thickness ≤6mm documented in at least 2 cycles on either:

  • Day of luteinizing hormone (LH) surge in natural cycle
  • Day of human chorionic gonadotropin (hCG) trigger in the setting of fresh IVF cycle
  • Day 14 of estradiol in the setting of frozen embryo transfer things (FET) cycles
3. Recurrent implantation failure, defined as failure to achieve a clinical pregnancy after transfer of at least four good-quality embryos in a minimum of three fresh or frozen transfer cycles in a woman under 40 years

Interventions

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.

Primary outcome measure

  • Change in endometrial thickness and implantation rates following treatment with Plerixafor at 6 month intervals up to 24 months, compared to controls [ Time Frame: Every 6 months from baseline up to 24 months ]

Central Contacts and Locations

Central contacts

Hugh S Taylor, MD

(203)-785-6949hugh.taylor@yale.edu

Michele Frank, BSN

(203)-785-6949Michele.Frank@yale.edu

Locations

Yale Fertility Center

Recruiting

Orange, Connecticut, United States, 06477

More Information

Sponsor

Hugh Taylor

Last update posted

Nov 12, 2025

Last verified

Nov, 2025

Keywords

  • bone marrow derived stem cells

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hugh Taylor on 2025-11-12.