Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT03762967
Status:
UNKNOWN
Last Update Posted:
2020-10-22
First Post:
2018-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Autologous Adipose-Derived Adult Stromal Vascular Cell Administration for Male Patients With Infertility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053713', 'term': 'Azoospermia'}, {'id': 'D009845', 'term': 'Oligospermia'}, {'id': 'D007248', 'term': 'Infertility, Male'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}, {'id': 'D000072001', 'term': 'Diet, Healthy'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study consist 40 patients in 4 groups. Two working groups and two control groups. Each group consist 10 Males.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-20', 'studyFirstSubmitDate': '2018-11-27', 'studyFirstSubmitQcDate': '2018-12-03', 'lastUpdatePostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sperm concentration in ejaculate', 'timeFrame': '1, 2, 3 month', 'description': 'Sperm quantity and quality will be evaluated with automatic sperm cout analyzer a month, two and three after injection of SVF. Total measures - 3.'}, {'measure': 'Spermatozoa in testicular biopsy', 'timeFrame': '3 month', 'description': 'Testicular sperm aspiration (TESA) will be performed after 3 month after SVF injection.'}], 'secondaryOutcomes': [{'measure': 'Testosterone', 'timeFrame': '3 month', 'description': 'Testosterone will be measured a three month after injection of SVF.'}, {'measure': 'Inhibin-B', 'timeFrame': '3 month', 'description': 'Inhibin-B will be measured a three month after injection of SVF.'}, {'measure': 'Follicle stimulating hormone (FSH)', 'timeFrame': '3 month', 'description': 'Follicle stimulating hormone will be measured a three month after injection of SVF.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autologous Stem Cell', 'Male infertility', 'Adipose-Derived stem cell', 'Azoospermia', 'Oligospermia'], 'conditions': ['Azoospermia', 'Oligozoospermia']}, 'descriptionModule': {'briefSummary': 'Severe Oligospermia (oligozoospermia) refer to semen with a low concentration of sperm and is a common finding in male infertility. Often semen with a decreased sperm concentration may also show significant abnormalities in sperm morphology and motility that affect Male fertility. The purpose of this study is to assess the ability of Autologous Adipose-Derived Adult Stromal Vascular Fraction (SVF) cells to stimulate Sertoli and spermatogonia cells and affect male fertility.', 'detailedDescription': 'This is an open-label study to evaluate efficiency of administration of Autologous Adipose-Derived Adult Stromal Vascular Fraction (SVF) in the testis in patients with oligospermia and azoospermia.\n\nForty men with several form oligozoospermia and azoospermia will be recruited for the study. 20 patients with same diagnosis served as a control with standard medications.Other patients -10 with oligospermia and 10 with azoospermia will receive standard medication and SVF injections.\n\nThe diagnosis of Azoospermia (Oligospermia) will be established on the basis of two and more semen analysis evaluations done at separate occasions and detailed history taking, physical examination and investigations (blood tests include hormon levels as testosteron. follicle stimulating hormone (FSH), luteinizing hormone (LH). karyotyping and testosterone levels, and may include testicular biopsy or transrectal ultrasound if indicated.\n\nThis study affect only Pretesticular and Testicular forms, without chromosomal aberration. SVF can produce a lot of cytokines ( as EGF, FGF, NGF, PDGF, VEGF, IGF, GMCSF, GCSF, TGF, Erythropoetin, TPO, BMP, HGF, GDF, Neurotrophins, MSF, SGF, GDF and growth factors) moreover the microvesicles and exosomes released by this cells can prevent cells from apoptosis and stimulate regenerative process of surrounding tissues and cells.\n\nSVF will be transplanted by an andrological surgeon through a standard surgical approach. Subjects will be monitored frequently for a total of one year after cell injection.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* idiopathic oligozoospermia (spermatozoid number \\<2x10\\^6/mL) - 10 patients\n* cryptozoospermia/azoospermia - 10 patients\n\nExclusion Criteria:\n\n* age before 18 or after 60 years old\n* heart insufficiency. stroke (during 1 year)\n* anemia\n* blood disease\n* pelvis bone trauma\n* chronic diseases in decompensation stage\n* skin diseases\n* tuberculosis\n* hyperprolactinaemia\n* hyper or hypothyreosis\n* obstructive zoospermia\n* sperm stimulating hormone therapy\n* Men with previous surgery in testis\n* Men with infectious genital diseases and anatomical abnormalities of the genital tract\n* Those with major medical problems such as malignancy, hepatitis B . C, etc. HIV\n* Chromosomal aberration (e.g. Y microdeletion, trisomy….)'}, 'identificationModule': {'nctId': 'NCT03762967', 'briefTitle': 'Autologous Adipose-Derived Adult Stromal Vascular Cell Administration for Male Patients With Infertility', 'organization': {'class': 'OTHER', 'fullName': 'State-Financed Health Facility "Samara Regional Medical Center Dinasty"'}, 'officialTitle': 'Efficiency Evaluation of Adipose-Derived Adult Stromal Vascular Cells in Patients With Spermatogenesis Disorders.', 'orgStudyIdInfo': {'id': '23032018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lipoaspiration and SVF introduction I.', 'description': 'Patients with azoospermia that introduce with standard treatment and Lipoaspiration and SVF introduction.', 'interventionNames': ['Biological: Lipoaspiration and SVF introduction.', 'Drug: Standard therapy.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard therapy I.', 'description': 'Patients with azoospermia that introduce with Standard therapy only.', 'interventionNames': ['Drug: Standard therapy.']}, {'type': 'EXPERIMENTAL', 'label': 'Lipoaspiration and SVF introduction II', 'description': 'Patients with oligospermia that introduce with standard treatment and Lipoaspiration and SVF introduction.', 'interventionNames': ['Biological: Lipoaspiration and SVF introduction.', 'Drug: Standard therapy.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard therapy II.', 'description': 'Patients with oligospermia that introduce with Standard therapy only.', 'interventionNames': ['Drug: Standard therapy.']}], 'interventions': [{'name': 'Lipoaspiration and SVF introduction.', 'type': 'BIOLOGICAL', 'description': 'Lipoaspiration, isolation of SVF and introduction into testis Interstitium.', 'armGroupLabels': ['Lipoaspiration and SVF introduction I.', 'Lipoaspiration and SVF introduction II']}, {'name': 'Standard therapy.', 'type': 'DRUG', 'otherNames': ['healthy diet, physical exertion eliminate. hormone therapy.'], 'description': 'Standard therapy include to give up bad habits, to establish a healthy diet, to eliminate excessive physical exertion. eliminate. In the case of endocrine disorders, hormone therapy is prescribed.', 'armGroupLabels': ['Lipoaspiration and SVF introduction I.', 'Lipoaspiration and SVF introduction II', 'Standard therapy I.', 'Standard therapy II.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '443095', 'city': 'Samara', 'country': 'Russia', 'facility': 'Medical Centre Dinasty', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}], 'overallOfficials': [{'name': 'Olga Tyumina, M.D. P.h.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical Centre Dinasty'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State-Financed Health Facility "Samara Regional Medical Center Dinasty"', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy director, Quality assurance director', 'investigatorFullName': 'Volchkov Stanislav', 'investigatorAffiliation': 'State-Financed Health Facility "Samara Regional Medical Center Dinasty"'}}}}