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Stem Cell Mobilization Agent
Stem Cell Mobilization with Plerixafor for Abnormal Endometrium
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 6 months from baseline up to 24 months
Awards & highlights
Study Summary
This trial will test whether a bone marrow stem cell mobilization using PLERIXAFOR is an effective medical therapy for the treatment of Asherman's Syndrome, Atrophic Endometrium, and Recurrent Implantation Failure.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in endometrial thickness and implantation rates following treatment with Plerixafor at 6 month intervals up to 24 months, compared to controls
Secondary outcome measures
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 • NCT0223187937%
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
5%
Iron Deficiency Anemia
5%
Cellulitis
5%
Arthritis
5%
Nausea
5%
Skin Infection
5%
Tinea capitis
5%
Aspartate aminotransferase increased
5%
Anemia
5%
Tinnitus
5%
Diarrhea
5%
Infectious Diarrhea
5%
Otitis media
5%
Bone mineral content decreased
5%
Hyperglycemia
5%
Hypernatremia
5%
Hyperkalemia
5%
Joint pain
5%
Low back pain
5%
Ovarian cyst
100%
80%
60%
40%
20%
0%
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:
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Plerixafor
2011
Completed Phase 3
~720
Find a Location
Who is running the clinical trial?
Hugh TaylorLead Sponsor
Valerie A Flores, MDPrincipal InvestigatorYale University
Hugh Taylor, MDPrincipal InvestigatorYale University
3 Previous Clinical Trials
727 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had at least 4 good-quality embryos transferred without pregnancy, under 40, treated at Yale.I am under 40, have had at least 4 good embryos transferred without pregnancy, and am a patient at Yale Fertility Clinic.I have AS, AE, or RIF.I have been diagnosed with endometriosis through surgery.I am a healthy woman, aged 18-40, not pregnant, with AS, AE, or RIF.I have had genital tuberculosis or an abnormal uterus shape detected by ultrasound.I have fibroids or polyps inside the wall or cavity of my uterus.I have a history of blood clotting disorders or sickle cell disease.I have had surgery related to internal uterine issues, including trauma, infection, or adhesions.I am a healthy woman and not pregnant.I am between 18 and 40 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Endometrial Disorders
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals aged 18 and over being sought out for participation in this experiment?
"The age range for this clinical trial is between 18 and 40 years old, in strict compliance with the eligibility requirements."
Answered by AI
Are there any current openings for this research endeavor?
"The research listed on clinicaltrials.gov is no longer recruiting patients - the initial post was made on September 1, 2022 and has since been updated July 13, 2022. However, there are 1588 other trials in need of participants at this time."
Answered by AI
Am I eligible to be part of this medical experiment?
"This clinical trial seeks 30 persons of legal age (18 to 40) who have been diagnosed with Asherman's Syndrome. To be eligible, applicants must also meet the following criteria: possess general good health, not currently pregnant, experience intrauterine trauma/infection and subsequent amenorrhea or hypo-amenorrhea due to intra-uterine adhesions for AS patients; ultrasound documentation of persistent endometrial thickness less than 6mm in AE cases; failure to achieve a successful pregnancy after transfer of four viable embryos across three fresh or frozen cycles if RIF is indicated and current treatment at Yale Fertility Clinic."
Answered by AI
Who else is applying?
What state do they live in?
Florida
What site did they apply to?
Yale Fertility Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
What questions have other patients asked about this trial?
How invasive is the treatment?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
I would like to become pregnant.
PatientReceived no prior treatments
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