Rejuvenation of Premature Ovarian Failure With Stem Cells (ROSE-1)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02696889|
Recruitment Status : Recruiting
First Posted : March 2, 2016
Last Update Posted : October 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Primary Ovarian Insufficiency Low Ovarian Reserve Premature Ovarian Failure||Procedure: ROSE-1 Protocol||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Improved diagnostic hormonal levels [ Time Frame: 18 months ]Reduction of 50% in FSH values; increase in AMH and Estradiol levels (30%)
- 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.
- 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
- 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.
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
|Contact: Riddhi Vyasemail@example.com|
|Contact: Patricia West-Thielkefirstname.lastname@example.org|
|United States, Illinois|
|University of Illinois at Chicago||Recruiting|
|Chicago, Illinois, United States, 60607|
|Contact: Ayman Al-Hendy, MD, PhD email@example.com|
|Contact: Riddhi Vyas firstname.lastname@example.org|
|Principal Investigator: Ayman Al-Hendy, MD, PhD|
|Sub-Investigator: Damiano Rondelli, MD|
|Sub-Investigator: Pritesh Patel, MD|
|Sub-Investigator: Nadim Mahmud, MD, PhD|
|Principal Investigator:||Ayman Al-Hendy, MD, PhD||University of Illinois at Chicago|