Clinical trial

Bone Marrow Derived Stem Cells Mobilization for Treatment of Asherman's Syndrome, Atrophic Endometrium, and Recurrent Implantation Failure

Name

2000026217

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).

Trial arms

Trial start

2023-11-01

Estimated PCD

2025-12-01

Trial end

2026-12-01

Status

Recruiting

Phase

Early phase I

Treatment

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.

Arms:

Endometrial Disorders

Size

Primary endpoint

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

Every 6 months from baseline up to 24 months

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

Updated at

2023-11-18

1 organization

1 drug

3 indications

Organization

Drug

Indication

Indication

Indication

Recurrent Implantation Failure