Rejuvenation of Premature Ovarian Failure With Stem Cells

NCT02696889 | Completed DMC

• 1 other identifier: 2018-0277
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Ovarian Insufficiency; Low Ovarian Reserve; Premature Ovarian Failure

Keywords

Infertility; Premature Ovarian Failure; Stem Cells; Amenorrhea; Low Ovarian Reserve; Ovarian Insufficiency; Premature menopause; Premature Ovarian Insufficiency

Outcome Measures

Primary Outcomes (1)

• Improved diagnostic hormonal levels

  Reduction of 50% in FSH values; increase in AMH and Estradiol levels (30%)

  18 months

Secondary Outcomes (3)

• Resumption of menses

  18 months

• Improved clinical hormone levels

  18 months

• Achievement of pregnancy

  18 months

Study Arms (1)

ROSE-1 Protocol

EXPERIMENTAL

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

Interventions

ROSE-1 Protocol PROCEDURE

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.

ROSE-1 Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60607, United States

Location

Related Publications (1)

• Igboeli P, El Andaloussi A, Sheikh U, Takala H, ElSharoud A, McHugh A, Gavrilova-Jordan L, Levy S, Al-Hendy A. Intraovarian injection of autologous human mesenchymal stem cells increases estrogen production and reduces menopausal symptoms in women with premature ovarian failure: two case reports and a review of the literature. J Med Case Rep. 2020 Jul 18;14(1):108. doi: 10.1186/s13256-020-02426-5.

  PMID: 32680541 DERIVED

MeSH Terms

Conditions

Primary Ovarian Insufficiency; Infertility; Amenorrhea; Menopause, Premature

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ayman Al-Hendy, MD, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: February 16, 2016
• First Posted: March 2, 2016
• Study Start: February 6, 2016
• Primary Completion: May 6, 2021
• Study Completion: May 6, 2021
• Last Updated: September 23, 2021

Record last verified: 2021-09

Locations

US (1)