Bone Marrow Derived Stem Cells Mobilization for Treatment of Abnormal Endometrium
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorHugh Taylor
About this trial
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
This trial accepts healthy volunteersQualifiers
Healthy, non pregnant females
ages ≥18 and ≤40 years old at time of enrollment
with either AS, AE, or RIF
For AS: surgical history of intrauterine trauma/infection, hypo/amenorrhea, intra-uterine adhesions
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Plerixafor
DrugA 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.
Treatment groups
90 Participants
are divided into 1 treatment groupGroup A: Endometrial DisordersExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Every 6 months from baseline up to 24 monthsSecondary outcomes
1
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.
Time frame
Every 3 months from baseline up to 24 months2
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
The 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 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.
Time frame
Every 3 months from baseline up to 24 months3
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
Change in endometrial thickness from baseline after treatment with Plerixafor compared to month 3 and month 6 measured using ultrasound. Thicker endometrium (\>6mm) indicates restoration of endometrial function.
Time frame
baseline, month 3 and month 6Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hugh Taylor
Lead sponsor
Yale University
Sponsor institution
Source ClinicalTrials.gov