Ignite Creation Date:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2026-01-06 @ 4:09 AM
Study NCT ID:
NCT03346967
Status:
COMPLETED
Last Update Posted:
2024-06-04
First Post:
2017-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes of Adipose Derived Mesenchymal Stem Cells on Sexual Hormone Deficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '30 patients with sexual hormone deficiency will be injected AD-MSCs'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-03', 'studyFirstSubmitDate': '2017-11-14', 'studyFirstSubmitQcDate': '2017-11-14', 'lastUpdatePostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum levels of follicle-stimulating hormone (FSH), Anti-Mullerian Hormone (AMH) and estradiol (E2) for female and testosterone level for male', 'timeFrame': 'up to the 12-month period following treatment', 'description': 'Comparison between Serum levels of follicle-stimulating hormone (FSH), Anti-Mullerian Hormone (AMH) and estradiol (E2) for female and testosterone level for male at pre and post AD-MSCs therapy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AD mesenchymal stem cells;sexual hormone deficiency'], 'conditions': ['Hormone Deficiency']}, 'referencesModule': {'references': [{'pmid': '28053944', 'type': 'RESULT', 'citation': 'Reed-Maldonado AB, Lue TF. The Current Status of Stem-Cell Therapy in Erectile Dysfunction: A Review. World J Mens Health. 2016 Dec;34(3):155-164. doi: 10.5534/wjmh.2016.34.3.155. Epub 2016 Dec 22.'}, {'pmid': '27077129', 'type': 'RESULT', 'citation': 'Haahr MK, Jensen CH, Toyserkani NM, Andersen DC, Damkier P, Sorensen JA, Lund L, Sheikh SP. Safety and Potential Effect of a Single Intracavernous Injection of Autologous Adipose-Derived Regenerative Cells in Patients with Erectile Dysfunction Following Radical Prostatectomy: An Open-Label Phase I Clinical Trial. EBioMedicine. 2016 Jan 19;5:204-10. doi: 10.1016/j.ebiom.2016.01.024. eCollection 2016 Mar.'}, {'pmid': '25811565', 'type': 'RESULT', 'citation': 'Charles-de-Sa L, Gontijo-de-Amorim NF, Maeda Takiya C, Borojevic R, Benati D, Bernardi P, Sbarbati A, Rigotti G. Antiaging treatment of the facial skin by fat graft and adipose-derived stem cells. Plast Reconstr Surg. 2015 Apr;135(4):999-1009. doi: 10.1097/PRS.0000000000001123.'}, {'pmid': '34129158', 'type': 'DERIVED', 'citation': 'Nguyen Thanh L, Dam PTM, Nguyen HP, Nguyen TT, To HM, Nguyen HB, Luu NA, Hoang DM. Can Autologous Adipose-Derived Mesenchymal Stem Cell Transplantation Improve Sexual Function in People with Sexual Functional Deficiency? Stem Cell Rev Rep. 2021 Dec;17(6):2153-2163. doi: 10.1007/s12015-021-10196-w. Epub 2021 Jun 15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and effectiveness of adipose derived mesenchymal stem cells (AD-MSCs) therapy on sexual hormone deficiency in the middle-aged patients', 'detailedDescription': 'The purpose of this study is to evaluate the safety and efficiency of adipose-derived mesenchymal stem cells in 30 patients with sexual hormone deficiency at Vinmec International Hospital, Hanoi, Vietnam'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'genderBased': True, 'genderDescription': '* 40 years to 65 years (Male) and from 40 years to menopause age (Female)\n* Male: decrease in libido, decrease in intercourse frequency, erectile dysfunction, Difficulty in concentration, testosterone level ≤ 12 nMol/dL\n* Female: reduced or absent menstruation after radiation exposure or chemotherapy; Hot flushes, excessive sweating, and anxiety, together with other symptoms associated with the menopause, AMH level ≤ 2 ng/ml and/or FSH level ≥ 10 mIU/ml.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 35 years to 70 years (Male) and from 35 years to menopause age (Female)\n* Male: decrease in libido, decrease in intercourse frequency, erectile dysfunction, Difficulty in concentration, testosterone level ≤ 12 nMol/dL\n* Female: reduced or absent menstruation after radiation exposure or chemotherapy; Hot flushes, excessive sweating, and anxiety, together with other symptoms associated with the menopause, AMH level ≤ 2 ng/ml and/or FSH level ≥ 10 mIU/ml.\n* Patients signed the informed consent form\n\nExclusion Criteria:\n\n* Surgery removal of endocrine glands\n* Abnormalities in the endrocrine glands\n* Hormone deficiency due to diabetes and other metabolic disorders\n* Active autoimmune diseases\n* Current usage of immunosuppressive drugs\n* Coagulation disorders\n* Allergy to anesthetic agents\n* Severe health conditions such as cancer, failure of heart, lung, liver or kidney\n* Active infections'}, 'identificationModule': {'nctId': 'NCT03346967', 'acronym': 'MSCSHD', 'briefTitle': 'Outcomes of Adipose Derived Mesenchymal Stem Cells on Sexual Hormone Deficiency', 'organization': {'class': 'OTHER', 'fullName': 'Vinmec Research Institute of Stem Cell and Gene Technology'}, 'officialTitle': 'Evaluation of Autologous Adipose Derived Mesenchymal Stem Cells (AD-MSCs) Therapy on Sexual Hormone Deficiency in the Middle-aged Patients: an Open-label, Single-group Clinical Trial', 'orgStudyIdInfo': {'id': 'VinmecRISCGT72'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stem cell Administration for female patients', 'description': 'Single Intravenous Administration of Autologous Adipose-derived Mesenchymal Stem Cells with Dosage at 1 million cells per body-weight kilogram for female patients', 'interventionNames': ['Combination Product: adipose-derived mesenchymal stem cells']}, {'type': 'EXPERIMENTAL', 'label': 'Stem cell Administration for male patients', 'description': 'Single Intravenous Administration of Autologous Adipose-derived Mesenchymal Stem Cells with Dosage at 1 million cells per body-weight kilogram for male patients', 'interventionNames': ['Combination Product: adipose-derived mesenchymal stem cells']}], 'interventions': [{'name': 'adipose-derived mesenchymal stem cells', 'type': 'COMBINATION_PRODUCT', 'description': 'Collect adipose-derived mesenchymal stem cells from the patients. Adipose-derived mesenchymal stem cells will be isolated, expanded and characterized in vitro under the GMP- grade procedure', 'armGroupLabels': ['Stem cell Administration for female patients', 'Stem cell Administration for male patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10000', 'city': 'Hanoi', 'country': 'Vietnam', 'facility': 'Vinmec Research Institute of Stem Cell and Gene Technology', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}], 'overallOfficials': [{'name': 'Liem Nguyen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vinmec Healthcare System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vinmec Research Institute of Stem Cell and Gene Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}