Bone Marrow Derived Stem Cells Mobilization for Treatment of Abnormal Endometrium

Last updated: December 17, 2024
Sponsor: Hugh Taylor
Overall Status: Active - Recruiting

Phase

1

Condition

Recurrent Pregnancy Loss

Treatment

Plerixafor

Clinical Study ID

NCT05343572
2000026217
No NIH funding
  • Ages 18-40
  • Female
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

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 leastfour good-quality embryos in a minimum of three fresh or frozen cycles in awoman under 40 years and currently being treated at Yale Fertility Clinic

Exclusion

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 uterineanomaly

  • Submucous or intracavitary fibroid, polyps

  • Currently pregnant

  • Personal history of thrombophilia or sickle cell disease

  • Inability to provide informed consent

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Plerixafor
Phase: 1
Study Start date:
November 01, 2023
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Yale Fertility Center

    Orange, Connecticut 06477
    United States

    Active - Recruiting

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