What side effects are associated with this type of intervention?

Common treatments for Asherman's Syndrome include surgical procedures like hysteroscopic adhesiolysis and medical therapies aimed at endometrial regeneration, such as hormone therapy and stem cell therapy. Known side effects of these treatments can include infection, bleeding, and uterine perforation from surgical interventions. Hormone therapies may cause side effects like nausea, headache, and breast tenderness. For stem cell therapies, potential side effects could include immune reactions and complications related to the mobilization and administration of stem cells, although specific data on PLERIXAFOR's side effects in this context are limited.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments for Asherman's Syndrome that involve stem cell mobilization similar to PLERIXAFOR (a CXCR4 antagonist). The current study on PLERIXAFOR aims to explore its efficacy in mobilizing autologous bone marrow stem cells for treating Asherman's Syndrome, Atrophic Endometrium, and Recurrent Implantation Failure. This represents a novel approach, as traditional treatments have primarily focused on surgical interventions and hormonal therapies.

What other types of research exist?

Currently, there are no specific novel alternatives to PLERIXAFOR mentioned in the provided context for the treatment of Asherman's Syndrome. Patients should consult with their healthcare provider to explore the latest research and clinical trials for potential new treatments.

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Stem Cell Mobilization Agent

Stem Cell Mobilization with Plerixafor for Abnormal Endometrium

Q: What is the mechanism of action of this treatment?

The most common treatments for Asherman's Syndrome (AS) aim to restore the endometrial lining and improve fertility. One promising approach involves the use of stem cell mobilization, particularly with CXCR4 antagonists like PLERIXAFOR. This treatment works by mobilizing autologous bone marrow-derived stem cells to the endometrium, promoting tissue regeneration and repair. This is crucial for AS patients as it addresses the root cause of the syndrome—scar tissue formation and endometrial damage—thereby enhancing the chances of successful implantation and pregnancy. By improving the endometrial environment, these treatments offer hope for better reproductive outcomes in women suffering from AS.

Phase < 1

Recruiting

Led By Valerie A Flores, MD

Research Sponsored by Hugh Taylor

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

For AS: surgical history of intrauterine trauma/infection, hypo/amenorrhea, intra-uterine adhesions

Must not have

Endometriosis (diagnosed by previous surgery)

History of genital tuberculosis or any ultrasound evidence of congenital uterine anomaly

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 6 months from baseline up to 24 months

Awards & highlights

Summary

This trial tests if a new treatment can help women with uterine lining issues by moving their own stem cells into their blood to repair the uterus. It aims to improve pregnancy chances for women with specific reproductive challenges.

Who is the study for?

This trial is for healthy, non-pregnant women aged 18-40 with Asherman's Syndrome (AS), Atrophic Endometrium (AE), or Recurrent Implantation Failure (RIF). Participants must have specific conditions like a thin endometrium (<6mm) or history of failed embryo transfers. Women with diminished ovarian reserve, current pregnancy, endometriosis, genital tuberculosis, thrombophilia, sickle cell disease, hydrosalpinx or uterine anomalies cannot join.

What is being tested?

The study tests the effectiveness of Plerixafor to mobilize autologous bone marrow stem cells as a treatment for AS, AE and RIF in women. It aims to see if this approach can improve the condition of the endometrium and increase chances of successful implantation.

What are the potential side effects?

Possible side effects from Plerixafor may include gastrointestinal symptoms such as diarrhea and nausea; injection site reactions; tiredness; headache; dizziness; and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I've had at least 4 good-quality embryos transferred without pregnancy, under 40, treated at Yale.

Select...

I have had surgery related to internal uterine issues, including trauma, infection, or adhesions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with endometriosis through surgery.

Select...

I have had genital tuberculosis or an abnormal uterus shape detected by ultrasound.

Select...

I have fibroids or polyps inside the wall or cavity of my uterus.

Select...

I have a history of blood clotting disorders or sickle cell disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 6 months from baseline up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 6 months from baseline up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 6 months from baseline up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

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

Side effects data

From 2021 Phase 2 & 3 trial • 20 Patients • NCT02231879

37%

Bone pain

32%

Upper Respiratory Tract Infection

26%

Weight gain

16%

Blood alkaline phosphatase increased

16%

Upper respiratory infection

16%

Injection Site Reaction

16%

Hyperuricemia

16%

Hypocalcemia

16%

Headache

16%

Rash

11%

Tooth extraction

11%

Herpes simplex

11%

Urinary Tract Infection

11%

Abscess

11%

Pharyngitis

11%

Tinea corporis

11%

Fracture

11%

Migraine

11%

Acute bronchitis

11%

Elective surgery

11%

Acute sinusitis

11%

Alanine aminotransferase increased

11%

Creatinine increased

11%

Knee pain

11%

Arthralgia

11%

Papular rash

11%

Pruritic rash

Iron Deficiency Anemia

Arthritis

Cellulitis

Nausea

Skin Infection

Tinea capitis

Aspartate aminotransferase increased

Anemia

Tinnitus

Diarrhea

Infectious Diarrhea

Otitis media

Bone mineral content decreased

Hyperglycemia

Hypernatremia

Hyperkalemia

Joint pain

Low back pain

Ovarian cyst

100%

80%

60%

40%

20%

Study treatment Arm

Plerixafor

G-CSF

Trial Design

1Treatment groups

Experimental Treatment

Group I: Endometrial DisordersExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Plerixafor

2011

Completed Phase 3

~710

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Asherman's Syndrome (AS) aim to restore the endometrial lining and improve fertility. One promising approach involves the use of stem cell mobilization, particularly with CXCR4 antagonists like PLERIXAFOR. This treatment works by mobilizing autologous bone marrow-derived stem cells to the endometrium, promoting tissue regeneration and repair. This is crucial for AS patients as it addresses the root cause of the syndrome—scar tissue formation and endometrial damage—thereby enhancing the chances of successful implantation and pregnancy. By improving the endometrial environment, these treatments offer hope for better reproductive outcomes in women suffering from AS.

Uterine administration of CXCL12 increases pregnancy rates in mice with induced endometriosis.Expression of CXCL12 and its receptor CXCR4 in patients with adenomyosis.