Bone Marrow Derived Stem Cells Mobilization for Treatment of Abnormal Endometrium

NCT ID: NCT05343572

Last Updated: 2025-11-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2027-12-31

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).

Detailed 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, AE, and RIF receiving PLERIXAFOR compared to historic controls that received existing standard of care therapy

Secondary Objectives: (assessed in participants who have not achieved pregnancy as of the timepoint):

• Endometrial thickness prior to treatment with PLERIXAFOR compared to endometrial thickness 3 and 6 months after treatment.

During this study, participants are asked to:

• Refrain from use of non-steroidal anti-inflammatory drugs (NSAIDs) from 2 weeks prior to the start of the surgery/PLERIXAFOR administration, and for the 30 days following surgery/ PLERIXAFOR administration.
• Abstain from intercourse for three months following surgery/PLERIXAFOR administration

• Assessment of menstrual bleeding pattern before and 3 and 6 months following treatment with PLERIXAFOR
• Assessment of endometrial blood flow before and 3 and 6 months following treatment with PLERIXAFOR
• Assessment of endometrial histology three months following treatment with PLERIXAFOR The study intervention consists of administration of PLERIXAFOR the evening prior to scheduled standard of care surgery for women with AS, AE or RIF, for peripheral mobilization of stem cells. PLERIXAFOR is administered via the subcutaneous route, as a single dose of 20mg.

The goal of this study is to determine if the administration of PLERIXAFOR for autologous, peripheral stem cell mobilization and administration will restore endometrial function in women with AS, AE, and RIF, and allow for pregnancy implantation.

Conditions

Asherman Syndrome; Atrophic Endometrium; Recurrent Implantation Failure

Keywords

bone marrow derived stem cells

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Plerixafor

Intervention Type: 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.

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hugh Taylor

OTHER

Sponsor Role: lead

Responsible Party

Hugh Taylor

Chair of Obstetrics, Gynecology and Reproductive Sciences

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hugh Taylor, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale Fertility Center

Orange, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Hugh S Taylor, MD

Role: CONTACT

Phone: (203)-785-6949

Email: hugh.taylor@yale.edu

Michele Frank, BSN

Role: CONTACT

Phone: (203)-785-6949

Email: Michele.Frank@yale.edu

Other Identifiers

No NIH funding

Identifier Type: OTHER

Identifier Source: secondary_id

2000026217

Identifier Type: -

Identifier Source: org_study_id