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Rejuvenation of Premature Ovarian Failure With Stem Cells (ROSE-1)

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ClinicalTrials.gov Identifier: NCT02696889
Recruitment Status : Recruiting
First Posted : March 2, 2016
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
Ayman Al-Hendy, University of Illinois at Chicago

Brief Summary:
The ROSE-1 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 or primary ovarian failure (POF or POI) and low ovarian reserves.

Condition or disease Intervention/treatment Phase
Primary Ovarian Insufficiency Low Ovarian Reserve Premature Ovarian Failure Procedure: ROSE-1 Protocol Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Stem Cell Therapy for Premature Ovarian Insufficiency and Low Ovarian Reserve
Actual Study Start Date : February 6, 2016
Estimated Primary Completion Date : May 6, 2020
Estimated Study Completion Date : May 6, 2021


Arm Intervention/treatment
Experimental: ROSE-1 Protocol
Patients with POF, POI or Low Ovarian Reserve choosing to enroll will be provided informed consent for Rejuvenation of Premature Ovarian Failure With Stem Cells (ROSE-1). They will undergo diagnosis and screening confirming diagnosis including History and Physical Exams, Labs and Diagnostic Procedures. Following final approval and under anesthesia, bone marrow aspiration with separation of the bone marrow derived stem cell fraction will be performed. Diagnostic laparoscopy will allow for assessment of pelvic anatomy and subsequent injection of the bone marrow derived stem cells into the right ovary.
Procedure: ROSE-1 Protocol
A bone marrow aspiration will be performed under anesthesia in preparation for a diagnostic laparoscopy for full evaluation of the pelvic anatomy. Following laparoscopy, injection of BMSCs into the right ovary will occur.




Primary Outcome Measures :
  1. Improved diagnostic hormonal levels [ Time Frame: 18 months ]
    Reduction of 50% in FSH values; increase in AMH and Estradiol levels (30%)


Secondary Outcome Measures :
  1. Resumption of menses [ Time Frame: 18 months ]
    Resumption of menses. Improved quality of life using the North American Menopausal Society (NAMS) validated menopause health questionnaire.

  2. Improved clinical hormone levels [ Time Frame: 18 months ]
    Improvement in hormonal levels toward normal ranges. Hormones may include FSH/LH; Estradiol/ progesterone;Inhibin; Anti- Mullerian Hormone

  3. Achievement of pregnancy [ Time Frame: 18 months ]
    Achievement of pregnancy by natural or assisted conception methods as may be deemed appropriate by the patient and her primary provider.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Able to understand and communicate in English language
  • Signed and dated informed consent
  • Female over the age of 18
  • Diagnosis of premature ovarian insufficiency: At least two menopausal FSH levels (≥ 40 IU/L) and/or Primary or secondary amenorrhea at least for 3-6 months OR Diagnosis of low ovarian reserve defined as: AMH < _0.42 ng/ML & FSH >20 IU/L, and/or failure of prior attempts of assisted reproductive techniques due to limited ovarian response (poor responder).
  • Normal karyotype 46, XX.
  • Presence of at least one ovary
  • Acceptable uterine anatomy (by any clinically and/or imaging acceptable methods)
  • Normal thyroid function as evidence by normal serum Thyroid Stimulating Hormone (TSH) levels.
  • Agree to report any pregnancy to the research staff immediately.
  • Willing and able to comply with study requirements and follow up instructions.
  • No other causes of female infertility in the subject

If subject is planning to pursue pregnancy: Presence of at least unilateral tubal patency (with any clinically acceptable methods).

Exclusion Criteria

  • Unable to understand and communicate in English language
  • Currently pregnant or breast-feeding
  • Has a history of, or evidence of current gynecologic malignancy within the past three years
  • Presence of adnexal masses indicating the need for further evaluation
  • Major mental health disorder that precludes participation in the study
  • Active substance abuse or dependence
  • Unfit or unwilling to undergo laparoscopy; has contraindication to laparoscopic surgery and/or general anesthesia
  • Current or recent (within the past 2 weeks) use of the following medications: Oral or systemic corticosteroids, Hormones (estrogen, progestins, oral contraceptives), Danazol, anticoagulants, herbal or botanical supplements with possible hormonal effects. Washout will be allowed.
  • Medical conditions that are contraindicated in pregnancy
  • Type I or Type II diabetes mellitus, or if receiving antidiabetic medications
  • Known significant anemia (Hemoglobin <8 g/dL).
  • Untreated deep venous thrombosis, and/or pulmonary embolus
  • Untreated cerebrovascular disease
  • Known heart disease (New York Heart Association Class II or higher).
  • Known Liver disease (defined as Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT)>2 times normal, or total bilirubin >2.5 mg/dL).
  • Known Renal disease (defined as Blood urea nitrogen (BUN)>30 mg/dL or serum creatinine > 1.6 mg/dL).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02696889


Contacts
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Contact: Riddhi Vyas rose-research@uic.edu
Contact: Patricia West-Thielke rose-research@uic.edu

Locations
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United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60607
Contact: Ayman Al-Hendy, MD, PhD       rose-research@uic.edu   
Contact: Riddhi Vyas       rose-research@uic.edu   
Principal Investigator: Ayman Al-Hendy, MD, PhD         
Sub-Investigator: Damiano Rondelli, MD         
Sub-Investigator: Pritesh Patel, MD         
Sub-Investigator: Nadim Mahmud, MD, PhD         
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
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Principal Investigator: Ayman Al-Hendy, MD, PhD University of Illinois at Chicago

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Responsible Party: Ayman Al-Hendy, Professor of Obstetrics and Gynecology, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02696889     History of Changes
Other Study ID Numbers: 2018-0277
First Posted: March 2, 2016    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ayman Al-Hendy, University of Illinois at Chicago:
Infertility
Premature Ovarian Failure
Stem Cells
Amenorrhea
Low Ovarian Reserve
Ovarian Insufficiency
Premature menopause
Premature Ovarian Insufficiency
Additional relevant MeSH terms:
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Primary Ovarian Insufficiency
Gonadal Dysgenesis
Turner Syndrome
Ovarian Diseases
Premature Birth
Menopause, Premature
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn