Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-30 @ 2:19 PM
Study NCT ID:
NCT05410834
Status:
UNKNOWN
Last Update Posted:
2022-06-08
First Post:
2022-06-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pro-vascular Regenerative Cell Exhaustion in Women With Polycystic Ovarian Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D002908', 'term': 'Chronic Disease'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum samples to be retained for 5 years'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-06', 'studyFirstSubmitDate': '2022-06-06', 'studyFirstSubmitQcDate': '2022-06-06', 'lastUpdatePostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'measure': 'Number of circulating ALDHhiSSCmid monocytes', 'timeFrame': 'Baseline', 'description': 'Difference in the number of circulating ALDHhi SSCmid monocytes with M1 vs M2 polarization between women with PCOS versus without PCOS'}, {'measure': 'Number of circulating ALDHhiSSClo primitive progenitor cells', 'timeFrame': 'Baseline', 'description': 'Difference in the number of circulating ALDHhi SSClo primitive progenitor cells in women with PCOS versus without PCOS'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Polycystic ovarian syndrome', 'Progenitor cells', "Women's Health", 'Insulin resistance', 'Chronic disease'], 'conditions': ['Polycystic Ovary Syndrome']}, 'referencesModule': {'references': [{'pmid': '30733805', 'type': 'BACKGROUND', 'citation': 'Vassalli 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': '29844207', 'type': 'BACKGROUND', 'citation': 'Bajuk 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': '33917519', 'type': 'BACKGROUND', 'citation': 'Rudnicka 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': '23303572', 'type': 'BACKGROUND', 'citation': 'Murri 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': '30847424', 'type': 'BACKGROUND', 'citation': 'Terenzi 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': '21308868', 'type': 'BACKGROUND', 'citation': 'Balber 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': '29226477', 'type': 'BACKGROUND', 'citation': 'Qadura 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.'}, {'pmid': '28618138', 'type': 'BACKGROUND', 'citation': 'Putman DM, Cooper TT, Sherman SE, Seneviratne AK, Hewitt M, Bell GI, Hess DA. Expansion of Umbilical Cord Blood Aldehyde Dehydrogenase Expressing Cells Generates Myeloid Progenitor Cells that Stimulate Limb Revascularization. Stem Cells Transl Med. 2017 Jul;6(7):1607-1619. doi: 10.1002/sctm.16-0472. Epub 2017 Jun 15.'}, {'pmid': '33554145', 'type': 'BACKGROUND', 'citation': 'Terenzi DC, Bakbak E, Trac JZ, Al-Omran M, Quan A, Teoh H, Verma S, Hess DA. Isolation and characterization of circulating pro-vascular progenitor cell subsets from human whole blood samples. STAR Protoc. 2021 Feb 1;2(1):100311. doi: 10.1016/j.xpro.2021.100311. eCollection 2021 Mar 19.'}, {'pmid': '21908093', 'type': 'BACKGROUND', 'citation': 'Xiong YL, Liang XY, Yang X, Li Y, Wei LN. Low-grade chronic inflammation in the peripheral blood and ovaries of women with polycystic ovarian syndrome. Eur J Obstet Gynecol Reprod Biol. 2011 Nov;159(1):148-50. doi: 10.1016/j.ejogrb.2011.07.012. Epub 2011 Sep 9.'}, {'pmid': '31198521', 'type': 'BACKGROUND', 'citation': 'Mohammadi M. Oxidative Stress and Polycystic Ovary Syndrome: A Brief Review. Int J Prev Med. 2019 May 17;10:86. doi: 10.4103/ijpvm.IJPVM_576_17. eCollection 2019.'}, {'pmid': '19324906', 'type': 'BACKGROUND', 'citation': 'Capoccia BJ, Robson DL, Levac KD, Maxwell DJ, Hohm SA, Neelamkavil MJ, Bell GI, Xenocostas A, Link DC, Piwnica-Worms D, Nolta JA, Hess DA. Revascularization of ischemic limbs after transplantation of human bone marrow cells with high aldehyde dehydrogenase activity. Blood. 2009 May 21;113(21):5340-51. doi: 10.1182/blood-2008-04-154567. Epub 2009 Mar 26.'}, {'pmid': '14688154', 'type': 'BACKGROUND', 'citation': 'Rotterdam ESHRE/ASRM-Sponsored PCOS consensus workshop group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS). Hum Reprod. 2004 Jan;19(1):41-7. doi: 10.1093/humrep/deh098.'}, {'pmid': '16269619', 'type': 'BACKGROUND', 'citation': 'Hess DA, Wirthlin L, Craft TP, Herrbrich PE, Hohm SA, Lahey R, Eades WC, Creer MH, Nolta JA. Selection based on CD133 and high aldehyde dehydrogenase activity isolates long-term reconstituting human hematopoietic stem cells. Blood. 2006 Mar 1;107(5):2162-9. doi: 10.1182/blood-2005-06-2284. Epub 2005 Nov 3.'}, {'pmid': '31477497', 'type': 'BACKGROUND', 'citation': 'Hess DA, Terenzi DC, Trac JZ, Quan A, Mason T, Al-Omran M, Bhatt DL, Dhingra N, Rotstein OD, Leiter LA, Zinman B, Sabongui S, Yan AT, Teoh H, Mazer CD, Connelly KA, Verma S. SGLT2 Inhibition with Empagliflozin Increases Circulating Provascular Progenitor Cells in People with Type 2 Diabetes Mellitus. Cell Metab. 2019 Oct 1;30(4):609-613. doi: 10.1016/j.cmet.2019.08.015. Epub 2019 Aug 30.'}, {'pmid': '33800490', 'type': 'BACKGROUND', 'citation': 'Aboeldalyl S, James C, Seyam E, Ibrahim EM, Shawki HE, Amer S. The Role of Chronic Inflammation in Polycystic Ovarian Syndrome-A Systematic Review and Meta-Analysis. Int J Mol Sci. 2021 Mar 8;22(5):2734. doi: 10.3390/ijms22052734.'}, {'pmid': '22899443', 'type': 'BACKGROUND', 'citation': 'Putman DM, Liu KY, Broughton HC, Bell GI, Hess DA. Umbilical cord blood-derived aldehyde dehydrogenase-expressing progenitor cells promote recovery from acute ischemic injury. Stem Cells. 2012 Oct;30(10):2248-60. doi: 10.1002/stem.1206.'}, {'pmid': '31053416', 'type': 'BACKGROUND', 'citation': 'Terenzi DC, Trac JZ, Teoh H, Gerstein HC, Bhatt DL, Al-Omran M, Verma S, Hess DA. Vascular Regenerative Cell Exhaustion in Diabetes: Translational Opportunities to Mitigate Cardiometabolic Risk. Trends Mol Med. 2019 Jul;25(7):640-655. doi: 10.1016/j.molmed.2019.03.006. Epub 2019 Apr 30.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Individuals with polycystic ovarian syndrome (PCOS) have been reported to be at higher risk of cardiovascular disease when compared to those without PCOS. While differential environmental exposures and genetic morphometries are believed to account in part for the difference, there is growing evidence that cardiometabolic risk factors can accelerate pro-vascular progenitor cell depletion and dysfunction. The cumulative effects that aberrant regenerative cell exhaustion (RCE) have on vessel repair accordingly increases the risk of atherothrombotic events.\n\nPCOS-RCE is an observational, cross-sectional, two-arm study that will evaluate the progenitor cell profiles of peripheral blood samples from 30 individuals (15 with PCOS, 15 without PCOS). The working hypothesis is that individuals with PCOS have innately different progenitor cell profiles that can be further altered by their environment and genotype. The resultant differences in RCE capability will affect the balance between pro-inflammatory and vessel repair functions that, in turn, contribute to the contrasting cardiometabolic risks exhibited between the two study cohorts.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be identified from primary care clinics in the Greater Toronto Area using paper-based and electronic medical records.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Capable and willing to provide informed consent\n* Females aged 30 and above\n* Must meet criteria for one of the following two groups:\n\n 1. Documented diagnosis of PCOS OR\n 2. Normal and regular menstrual cycles with no known diagnosis of PCOS\n\nExclusion Criteria:\n\n* Menopause, as defined by 12 months of amenorrhea\n* Known causes of irregular menstrual bleeding caused by conditions other than PCOS\n* Known secondary causes of ovulatory dysfunction and/or hyperandrogenism\n* Current pregnancy, active lactation, or less than 6 months postpartum\n* Ongoing treatment with ovulation-inducing medication\n* History of hysterectomy and/or bilateral oophorectomy\n* Severe congestive heart failure (as defined by New York Heart Association - class IV)\n* Any life-threatening disease expected to result in death within the next 2 years\n* 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.\n* Known severe liver disease\n* Known acquired immunodeficiency syndrome such as HIV\n* Current treatment with systemic or oral corticosteroid therapy or other immunosuppressive agents\n* Known autoimmune disorder (exception: type 1 diabetes)\n* Active infectious disease requiring antibiotic or anti-viral agents'}, 'identificationModule': {'nctId': 'NCT05410834', 'acronym': 'PCOS-RCE', 'briefTitle': 'Pro-vascular Regenerative Cell Exhaustion in Women With Polycystic Ovarian Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Canadian Medical and Surgical Knowledge Translation Research Group'}, 'officialTitle': 'The Characterization of Pro-vascular Regenerative Cell Exhaustion in Women With Polycystic Ovarian Syndrome', 'orgStudyIdInfo': {'id': 'Pro00063366'}}, 'armsInterventionsModule': {'armGroups': [{'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'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L3Y 2N1', 'city': 'Newmarket', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Shakkeela Padanilathu Kunjummar, MD', 'role': 'CONTACT', 'phone': '9058538525'}, {'name': 'Christina Austin', 'role': 'CONTACT', 'phone': '9058538525'}], 'facility': 'Centrum Services Newmarket', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'zip': 'M1S 4N6', 'city': 'Scarborough Village', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Subodh Verma, MD PhD', 'role': 'CONTACT'}], 'facility': 'Diagnostic Assessment Centre', 'geoPoint': {'lat': 43.73899, 'lon': -79.22124}}, {'zip': 'L4L 1A6', 'city': 'Woodbridge', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Kristin Terenzi, MD', 'role': 'CONTACT', 'phone': '9058568086'}], 'facility': 'Langstaff Medical Centre', 'geoPoint': {'lat': 43.78341, 'lon': -79.59962}}], 'centralContacts': [{'name': 'Irene Firoz, MB BCh BAO', 'role': 'CONTACT', 'email': 'irene.firoz@mail.utoronto.ca', 'phone': '6478194929'}, {'name': 'Aishwarya Krishnaraj, BScH', 'role': 'CONTACT', 'email': 'aishy.krishnaraj@mail.utoronto.ca'}], 'overallOfficials': [{'name': 'Subodh Verma, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toronto'}, {'name': 'David A Hess, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Western Ontario, Canada'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Canadian Medical and Surgical Knowledge Translation Research Group', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}