Clinical Trial: Rejuvenation of Premature Ovarian Failure With Stem Cells

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Autologous Stem Cell Therapy for Premature Ovarian Failure

Brief Summary: The ROSE study is designed to determine the efficacy of bone marrow derived stem cell therapy on ovarian function recovery in subjects with idiopathic and other types of premature ovarian failure (POF)

Detailed Summary:

Premature ovarian failure (POF) is defined as hypergonadotropic ovarian failure occurring prior to age 40 . It is surprisingly common and affects approximately 1% of women below the age of 40. The incidence is 10% to 28% in women with primary amenorrhea and 4% to 18% in women with secondary amenorrhea . The clinical manifestations include amenorrhea and abnormally high levels of luteinizing (LH) and follicle stimulating hormone (FSH). The etiology of POF is unknown in most cases. It can be caused by combination of inherited conditions, immune disorders, environmental toxins and iatrogenic injury. The majority of patients with POF are considered to have idiopathic premature ovarian failure because usually no cause can be identified . POF has been shown to be associated with an increased incidence of other conditions, including Alzheimer's, cardiovascular and immune system diseases, metabolic syndrome, osteoporosis, diabetes and cancer of reproductive organs. POF is characterized by loss of secondary follicles, arrested folliculogenesis, decreased estrogen production, and infertility . The mechanism of ovarian failure is most likely accelerated follicular atresia but detailed pathogenesis is yet to be fully understood .

In women younger than 40, at least two menopausal FSH levels (≥40 IU/L) will be sufficient for the diagnosis of POF. It is not essential to have amenorrhea for the diagnosis of POF, because spontaneous menstrual cycles can sometimes be seen after the diagnosis as well. Resumption of normal ovarian function, albeit temporary, in patients with normal karyotypes has been documented in 10 to 20% of patient; thus, resumption of fertility is possible .

No presently available therapeutic intervention has been proven effective in restoring normal fertility in patients with POF. Various attempts at ovarian stimu
Sponsor: MD Stem Cells

Current Primary Outcome: Positive Pregnancy Test [ Time Frame: 12 months ]

Following the ROSE Protocol, subjects will be instructed to resume normal unprotected sexual intercourse as soon as possible and to continue for 12 months with monitoring of pregnancy test or until clinical pregnancy is confirmed.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Resumption of Menses [ Time Frame: 12 months ]
    With POF the normal menstrual cycle is disrupted and normal menses does not occur. Patients will monitor for resumption of menses.
  • Improvement in hormone levels [ Time Frame: 12 months ]
    Improvement in hormonal levels toward normal ranges. Hormones may include FSH/LH; Estradiol/ progesterone;Inhibin; Anti- Mullerian Hormone


Original Secondary Outcome: Same as current

Information By: MD Stem Cells

Dates:
Date Received: February 16, 2016
Date Started: February 2016
Date Completion: February 2020
Last Updated: January 1, 2017
Last Verified: January 2017