Clinical trial · Observational
Pro-vascular Regenerative Cell Exhaustion in Women With Polycystic Ovarian Syndrome
The Characterization of Pro-vascular Regenerative Cell Exhaustion in Women With Polycystic Ovarian Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
PCOS-RCE is an observational, cross-sectional, two-arm study that is aimed at determining if an established diagnosis of polycystic ovarian syndrome (PCOS) influences the number of blood vessel-forming stem cells in the bloodstream. Circulating progenitor cells will be enumerated and the distribution patterns of these cell types will be assessed to determine if these parameters differ between individuals with PCOS and individuals without PCOS. Specifically, this study will evaluate if differential regenerative cell exhaustion (RCE) may account, at least in part, for the differences in cardiovascular risk reported between individuals with a diagnosis of PCOS and those without.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Individuals with polycystic ovarian syndrome
- description
- Individuals with a documented diagnosis of polycystic ovarian syndrome
- label
- Individuals without polycystic ovarian syndrome
- description
- Individuals without a known diagnosis of polycystic ovarian syndrome but with regular menstrual cycles
Primary outcomes (1)
- measure
- Frequency of circulating ALDHhiSSChi granulocytes
- timeFrame
- Baseline
- description
- Difference in the frequency of circulating ALDHhi SSChi granulocytes between women with PCOS versus without PCOS
Secondary outcomes (2)
- measure
- Number of circulating ALDHhiSSCmid monocytes
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * Capable and willing to provide informed consent * Females aged 30 and above * Must meet criteria for one of the following two groups: 1. Documented diagnosis of PCOS OR 2. Normal and regular menstrual cycles with no known diagnosis of PCOS Exclusion Criteria: * Menopause, as defined by 12 months of amenorrhea * Known causes of irregular menstrual bleeding caused by conditions other than PCOS * Known secondary causes of ovulatory dysfunction and/or hyperandrogenism * Current pregnancy, active lactation, or less than 6 months postpartum * Ongoing treatment with ovulation-inducing medication * History of hysterectomy and/or bilateral oophorectomy * Severe congestive heart failure (as defined by New York Heart Association - class IV) * Any life-threatening disease expected to result in death within the next 2 years * Any malignancy not considered cured. A subject is considered cured if there has been no evidence of cancer recurrence for the 5 years prior to screening. * Known severe liver disease * Known acquired immunodeficiency syndrome such as HIV * Current treatment with systemic or oral corticosteroid therapy or other immunosuppressive agents * Known autoimmune disorder (exception: type 1 diabetes) * Active infectious disease requiring antibiotic or anti-viral agents
References
Publications (18)
- BACKGROUNDVassalli G. Aldehyde Dehydrogenases: Not Just Markers, but Functional Regulators of Stem Cells. Stem Cells Int. 2019 Jan 13;2019:3904645. doi: 10.1155/2019/3904645. eCollection 2019. PMID 30733805
- BACKGROUNDBajuk Studen K, Pfeifer M. Cardiometabolic risk in polycystic ovary syndrome. Endocr Connect. 2018 Jul;7(7):R238-R251. doi: 10.1530/EC-18-0129. Epub 2018 May 29. PMID 29844207
- BACKGROUNDRudnicka E, Suchta K, Grymowicz M, Calik-Ksepka A, Smolarczyk K, Duszewska AM, Smolarczyk R, Meczekalski B. Chronic Low Grade Inflammation in Pathogenesis of PCOS. Int J Mol Sci. 2021 Apr 6;22(7):3789. doi: 10.3390/ijms22073789. PMID 33917519
- BACKGROUNDMurri M, Luque-Ramirez M, Insenser M, Ojeda-Ojeda M, Escobar-Morreale HF. Circulating markers of oxidative stress and polycystic ovary syndrome (PCOS): a systematic review and meta-analysis. Hum Reprod Update. 2013 May-Jun;19(3):268-88. doi: 10.1093/humupd/dms059. Epub 2013 Jan 9. PMID 23303572
- BACKGROUNDTerenzi DC, Al-Omran M, Quan A, Teoh H, Verma S, Hess DA. Circulating Pro-Vascular Progenitor Cell Depletion During Type 2 Diabetes: Translational Insights Into the Prevention of Ischemic Complications in Diabetes. JACC Basic Transl Sci. 2018 Nov 5;4(1):98-112. doi: 10.1016/j.jacbts.2018.10.005. eCollection 2019 Feb. PMID 30847424
- BACKGROUNDBalber AE. Concise review: aldehyde dehydrogenase bright stem and progenitor cell populations from normal tissues: characteristics, activities, and emerging uses in regenerative medicine. Stem Cells. 2011 Apr;29(4):570-5. doi: 10.1002/stem.613. PMID 21308868
- BACKGROUNDQadura M, Terenzi DC, Verma S, Al-Omran M, Hess DA. Concise Review: Cell Therapy for Critical Limb Ischemia: An Integrated Review of Preclinical and Clinical Studies. Stem Cells. 2018 Feb;36(2):161-171. doi: 10.1002/stem.2751. Epub 2018 Jan 3.