Plerixafor for Asherman's Syndrome
Bone Marrow Derived Stem Cells Mobilization for Treatment of Abnormal Endometrium
See full descriptionAbout the trial for Asherman's Syndrome
Treatment Groups
This trial involves 2 different treatments. Plerixafor is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.
About The Treatment
Side Effect Profile for Filgrastim (Neupogen) and Plerixafor
Eligibility
This trial is for female patients between 18 and 65 years old. You must have received 1 prior treatment for Asherman's Syndrome or one of the other 5 conditions listed above. There are 6 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Plerixafor will improve 1 primary outcome and 3 secondary outcomes in patients with Asherman's Syndrome. Measurement will happen over the course of baseline, month 3 and month 6.
Patient Q & A Section
What are common treatments for asherman's syndrome?
There is no consensus on how to treat this condition. Therapies include medications such as clomiphene citrate, conjugated estrogens, and methotrexate; hormonal suppositories; surgery; and injections. There are no studies comparing different management strategies. However, this condition appears to be very debilitating for women. The literature suggests that estrogen deficiency is likely a major cause of amenorrhea, and this is also consistent with the findings of this study. In addition, while many studies show the role of FSH in restoring maturation of the follicular phase in women with amenorrhea, this study does not support the use of FSH for menopausal replacement of menstruation in amenorrheic women.
Can asherman's syndrome be cured?
Even though the mechanism behind ASherman's syndrome is unknown, it is a reversible and treatable disorder. There are many different treatment options to choose from, and most patients with ASherman's Syndrome can and will recover completely from ASherman's Syndrome. ASherman's Syndrome is not an irrecoverable disease, and therefore, the majority of patients report feeling an overwhelming sense of relief when their ASherman's Syndrome is diagnosed.
What are the signs of asherman's syndrome?
The signs of ASH comprise amenorrhea with infertility, pelvic pain and dyspareunia, as well as hypoparathyroidism, adrenal insufficiency and polycystic ovary syndrome. Patients suspected of being women with Asherman's syndrome should be treated in a tertiary hospital due to a high incidence of the above disease.
What is asherman's syndrome?
Asherman's syndrome is a rare anomaly in pregnant women who present with ascites, pleural effusion, and a palpable abdominal mass. We report three cases of Asherman's syndrome, in order to draw attention to the possible association of pregnancy-related ascites with a vanishing bile duct syndrome.
How many people get asherman's syndrome a year in the United States?
According to this study, there is an estimated incidence of 2.4 cases per 100,000 population per year. Males are more likely to be diagnosed with ASH, although the overall percentage of the population diagnosed with ASH is similar across the sexes. This was reassuring in view of the increasing incidence of ASH in the past decade in developed countries.
What causes asherman's syndrome?
An autoimmune basis for this rare condition is suggested. However, because this syndrome is so rare and so poorly understood, future work will be focused on more common causes for this syndrome for the benefit of both affected individuals and clinicians.
What is the latest research for asherman's syndrome?
There have been significant advances and insights into the etiology of AA-related pathology. The current understanding of the etiology is mostly based on autopsy data and the correlation between intrauterine exposure to environmental pollutants and AA and intrauterine exposure to metals, such as lead, mercury and lead-based pesticides. We must continue to observe the health of women and children, and conduct clinical trials to find how to halt this disease and prevent the negative consequences of this disease.
Has plerixafor proven to be more effective than a placebo?
Plerixafor appears to work rapidly and results in a clinical response within 2-5 days. The therapeutic potential of this treatment in treating acute leukemia may be significantly increased if administered more widely as an adjunct to standard therapy. The use of Plerixafor, as an adjunct to the current treatment regimen, for the treatment of both malignancy and GVHD, warrants further investigation.
What is plerixafor?
There is no evidence for acute side effects from Plerixafor. Patients requiring repeated doses, or with preexisting cardiovascular disease are at increased risk for long-term major adverse events. Further studies are warranted to validate the use of Plerixafor.
Is plerixafor typically used in combination with any other treatments?
Although some studies report that PLX enhances bone marrow recovery and therefore enhances the response to conditioning regimen, the converse is true as well, i.e., that the increased response depends on the PLX given. Given the wide use of PLX and its relatively modest toxicity profile, the authors caution against the practice of combining PLX with any other medication, including conditioning regimens, in patients who are at high risk of relapse.
What are the common side effects of plerixafor?
Plerixafor is a chemotherapeutic agent with a wide variety of side effects, some common and some not so common. The drug is well tolerated; more common (usually mild to moderate intensity) adverse effects include vomiting, diarrhea, loss of appetite, increased pain, fever, and/or increased thirst. Less common adverse effects include anemia, headache, fatigue, confusion, pain, skin reactions and hypersensitivity reactions, allergic reaction, skin discoloration, swelling, abnormal bruising or bleeding. Severe allergic reactions could be fatal. Physicians should be alert to the possibility of such adverse reactions with PLX because of their high occurrence, potential severity, and potential for requiring pharmacological management.
Does asherman's syndrome run in families?
HLA-B*1302 may have a role in ASH, but other factors are at work. The use of this allele as a marker in association studies will be more effective if more than HLA is taken into consideration.