NCT02696889: ROSE-1

Rejuvenation of Premature Ovarian Failure With Stem Cells

Completed NA Last updated 23 September 2021

What this trial tests

NA trial testing ROSE-1 Protocol in Primary Ovarian Insufficiency in 3 participants. Completed in 6 May 2021.

Timeline

6 February 2016

Primary endpoint
6 May 2021

6 May 2021

Quick facts

Lead sponsor	University of Illinois at Chicago
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	6 February 2016
Primary completion	6 May 2021
Estimated completion	6 May 2021
Sites	1 location across United States

Drugs / interventions tested

• ROSE-1 Protocol

Conditions studied

• Primary Ovarian Insufficiency — all drugs for Primary Ovarian Insufficiency →
• Low Ovarian Reserve — all drugs for Low Ovarian Reserve →
• Premature Ovarian Failure — all drugs for Premature Ovarian Failure →

Sponsor

University of Illinois at Chicago

Who can join

18 and older, female only, with Primary Ovarian Insufficiency or Low Ovarian Reserve. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Igboeli P, El Andaloussi A, Sheikh U, Takala H, et al · · 2020 · cited 61× · PMID 32680541 · DOI 10.1186/s13256-020-02426-5
2. Application of Stem Cell Therapy for Infertility.
   Saha S, Roy P, Corbitt C, Kakar SS. · · 2021 · cited 54× · PMID 34203240 · DOI 10.3390/cells10071613
3. Mesenchymal stromal/stem cells and their exosomes for restoration of spermatogenesis in non-obstructive azoospermia: a systemic review.
   Zhankina R, Baghban N, Askarov M, Saipiyeva D, et al · · 2021 · cited 49× · PMID 33823925 · DOI 10.1186/s13287-021-02295-9
4. Recent trends in stem cell therapy for premature ovarian insufficiency and its therapeutic potential: a review.
   Na J, Kim GJ. · · 2020 · cited 44× · PMID 32576209 · DOI 10.1186/s13048-020-00671-2
5. Stem Cell Paracrine Signaling for Treatment of Premature Ovarian Insufficiency.
   Polonio AM, García-Velasco JA, Herraiz S. · · 2020 · cited 22× · PMID 33716956 · DOI 10.3389/fendo.2020.626322
6. Current Status and Future Prospects of Stem Cell Therapy for Infertile Patients with Premature Ovarian Insufficiency.
   Kim HK, Kim TJ. · · 2024 · cited 20× · PMID 38397479 · DOI 10.3390/biom14020242
7. Bone marrow mesenchymal stem cells in premature ovarian failure: Mechanisms and prospects.
   Huang Y, Zhu M, Liu Z, Hu R, et al · · 2022 · cited 20× · PMID 36389844 · DOI 10.3389/fimmu.2022.997808
8. In Vitro Generation of Oocyte Like Cells and Their In Vivo Efficacy: How Far We have been Succeeded.
   Bharti D, Jang SJ, Lee SY, Lee SL, et al · · 2020 · cited 19× · PMID 32120836 · DOI 10.3390/cells9030557