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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 : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
University of Illinois at Chicago

Study Description
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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

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Study Design
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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

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Arms and Interventions
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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; biopsy of the right ovary and subsequent injection of the bone marrow derived stem cells into the right ovary.

Ovarian injection of separated bone marrow stem cell fraction will be performed.

 Procedure: ROSE-1 Protocol
Laparoscopy followed by injection of BMSC fraction in right ovary


Outcome Measures
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Primary Outcome Measures :
  1. Improved diagnostic hormonal levels [ Time Frame: 12 months ]
    Reduction of 50% in FSH values; increase in AMH and Estradiol levels (30%)


Secondary Outcome Measures :
  1. Resumption of menses [ Time Frame: 12 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: 12 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: 12 months ]
    Achievement of pregnancy by natural or assisted conception methods as may be deemed appropriate by the patient and her primary provider.


Eligibility Criteria
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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

  • 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
  • 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
  • Presence of at least unilateral tubal patency (with any clinically acceptable methods),
  • Acceptable uterine anatomy (by any clinically and/or imaging acceptable methods)
  • No male infertility as assessed by normal semen analysis parameters and no sexual dysfunction
  • Normal thyroid function as evidence by normal serum Thyroid Stimulating Hormone (TSH) levels, normal anti-microsomal antibodies.
  • Agree to report any pregnancy to the research staff immediately.
  • Willing and able to comply with study requirements and follow up instructions.
  • Planning and/or willing to attempt to get pregnant as part of the experimental protocol.
  • No other causes of female infertility in the subject

Exclusion Criteria

  • 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).
Contacts and Locations
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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: Ashley McHugh 312-355-1385 aballa4@uic.edu
Contact: Riddhi Vyas 312-996-2348 rvyas4@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       aalhendy@uic.edu   
Contact: Ashley McHugh    312-355-1385    aballa4@uic.edu   
Principal Investigator: Ayman Al-Hendy, MD, PhD         
Sub-Investigator: Humberto Scoccia, MD         
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
More Information
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Responsible Party: University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02696889     History of Changes
Other Study ID Numbers: 723327-8
First Posted: March 2, 2016    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We have not made this decision.

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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 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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Premature Birth
Primary Ovarian Insufficiency
Menopause, Premature
Gonadal Dysgenesis
Turner Syndrome
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Ovarian Diseases
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