Bone Marrow Derived Stem Cells Mobilization for Treatment of Abnormal Endometrium

NCT05343572 | Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: 2000026217No NIH funding
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

bone marrow derived stem cells

Outcome Measures

Primary Outcomes (1)

• Change in endometrial thickness and implantation rates following treatment with Plerixafor at 6 month intervals up to 24 months, compared to controls

  Change in endometrial thickness post treatment compared to historic controls that received existing standard of care therapy, measured using ultrasound. Thicker endometrium (\>6mm) indicates restoration of endometrial function.

  Every 6 months from baseline up to 24 months

Secondary Outcomes (3)

• Change in endometrial thickness and implantation rates with Plerixafor in women with AS, AE and RIF at 3 month intervals, compared to baseline/pre-treatment

  Every 3 months from baseline up to 24 months

• Difference in ongoing pregnancy and live birth rates in women with AS, AE and RIF following treatment with Plerixafor at 3 month intervals, compared to baseline/pre-treatment

  Every 3 months from baseline up to 24 months

• Change in endometrial thickness from baseline after treatment with Plerixafor at month 3 and month 6 for participants that have not achieved pregnancy as of the timepoint

  baseline, month 3 and month 6

Study Arms (1)

Endometrial Disorders

EXPERIMENTAL

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

Drug: Plerixafor

Interventions

Plerixafor DRUG

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.

Endometrial Disorders

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, non pregnant females
• ages ≥18 and ≤40 years old at time of enrollment
• with either AS, AE, or RIF
• For AS: surgical history of intrauterine trauma/infection, hypo/amenorrhea, intra-uterine adhesions
• for AE: US documentation of persistent, \<6mm endometrial thickness
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hugh Taylor: lead

Study Sites (1)

Yale Fertility Center

Orange, Connecticut, 06477, United States

RECRUITING

MeSH Terms

Conditions

Gynatresia

Interventions

plerixafor

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Hugh Taylor, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hugh S Taylor, MD

CONTACT

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

Michele Frank, BSN

CONTACT

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chair of Obstetrics, Gynecology and Reproductive Sciences

Model Details: This is a pilot, open-label, non-randomized study to investigate the use of autologous bone marrow derived stem cells (peripheral mobilization) for cell-based therapy in treating AS, AE, and RIF.

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 25, 2022
• Study Start: November 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)