Bone Marrow Derived Stem Cells Mobilization for Treatment... | NCT05343572

NCT05343572

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
No NIH funding	Other Identifier	11.15.23

Status Module

Oversight Module

Description Module

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.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Endometrial Disorders	Experimental	Three groups of patients, with 10 subjects per group: 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. 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 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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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	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 will be assessed. Less atrophy, less fibrosis, greater blood vessel formation and greater endometrial blood flow on ultrasound, compared to historic controls is indicative of restoration of endometrial function.

Eligibility Module

Contacts/Locations Module

Name	Role	Phone	Extension	Email
Hugh S Taylor, MD	Contact	(203)-785-6949		hugh.taylor@yale.edu
Michele Frank, BSN	Contact	(203)-785-6949		Michele.Frank@yale.edu

Name	Affiliation	Role
Hugh Taylor, MD	Yale University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Yale Fertility Center	Recruiting	Orange	Connecticut	06477	United States

IPD Sharing Statement Module

Condition Browse Module

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases