Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2026-02-28 @ 3:29 AM
Study NCT ID:
NCT01742533
Status:
UNKNOWN
Last Update Posted:
2012-12-05
First Post:
2012-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stem Cell Therapy Combined Hormone Replacement Therapy in Patients With Premature Ovarian Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016649', 'term': 'Primary Ovarian Insufficiency'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020249', 'term': 'Hormone Replacement Therapy'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2014-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-12-02', 'studyFirstSubmitDate': '2012-11-26', 'studyFirstSubmitQcDate': '2012-12-02', 'lastUpdatePostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Level of follicle-stimulating hormone', 'timeFrame': '48 weeks after treatment'}], 'secondaryOutcomes': [{'measure': 'Uterine and Ovary characteristics of B ultrasound， including Uterine/Ovarian size and Blood Flow', 'timeFrame': '48 weeks after treatment'}, {'measure': 'Modified Kupperman Score', 'timeFrame': '48 weeks after treatment'}, {'measure': 'Incidence of Adverse Events and Serious Adverse Events', 'timeFrame': '48 weeks after treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hormone Replacement Therapy，', 'Premature Ovarian Failure，', 'Stem Cell Therapy'], 'conditions': ['Premature Ovarian Failure，']}, 'descriptionModule': {'briefSummary': 'Premature ovarian failure (POF) refers the occurrence of amenorrhoea, elevated serum gonadotrophins and hypoestrogenism levels in female before the age of 40. It has important physical and psychological consequences/impact in those patients.\n\nPremature ovarian failure (POF) is currently managed by non-physiological sex steroid regimens which are inadequate at optimizing uterine characteristics.\n\nHuman umbilical cord mesenchymal stem cells (hUCMSCs) and human cord blood mononuclear cells (hCBMNCs) have been shown to have the ability to modulate the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy for POF.\n\nIn this study, the safety and efficacy of hUCMSCs and hCBMNCs transplantation combined with Hormone Replacement Therapy will be evaluated in patients with Premature Ovarian Failure. Participants will be followed for an expected average of 48 weeks.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between age 18- 39 years, Female only.\n* Diagnosed with Premature Ovarian Failure，and currently receiving Hormone Replacement Therapy;\n* Willing to sign the Informed Consent Form.\n\nExclusion Criteria:\n\n* Fragile X chromosome.\n* polycystic ovary syndrome.\n* HIV+.\n* Autoimmune disease, e.g. lupus erythematosus, multiple sclerosis.\n* Severe pulmonary and hematological disease, malignancy or hypo-immunity.\n* Currently undertaking other treatment that may affect the safety/efficacy of stem cells.\n* Pregnancy or lactation\n* Enrollment in other trials in the last 3 months. • Other criteria the investigator consider improper for inclusion.'}, 'identificationModule': {'nctId': 'NCT01742533', 'briefTitle': 'Stem Cell Therapy Combined Hormone Replacement Therapy in Patients With Premature Ovarian Failure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shenzhen Beike Bio-Technology Co., Ltd.'}, 'officialTitle': 'A Phase Ι/Π Study of Human Cord Blood Mononuclear Cells and Human Umbilical Cord Mesenchymal Stem Cells Transplantation Combined With Hormone Replacement Therapy in Patients With Premature Ovarian Failure', 'orgStudyIdInfo': {'id': 'BKCR-POF-1(Ⅰ)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group1 : HRT plus hUCMSCs treatment:', 'description': 'Participants will be given HRT plus human cord mesenchymal stem cells transplantation with a 12 menstrual Cycle follow-up.', 'interventionNames': ['Biological: human umbilical cord mesenchymal stem cells']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: HRT plus hCBMNCs and hUCMSCs therapy', 'description': 'Participants will be given HRT plus combination of hCBMNCs together with hUCMSCs transplantation with a 12 menstrual Cycle follow-up.', 'interventionNames': ['Biological: hUCMSCs and hCBMNCs']}, {'type': 'EXPERIMENTAL', 'label': 'Group3 : HRT plus hCBMNCs treatment:', 'description': 'Participants will be given HRT plus human cord blood mononuclear cells transplantation with a 12 menstrual Cycle follow-up.', 'interventionNames': ['Biological: human cord blood mononuclear cells']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4:Hormone Replacement Therapy', 'description': 'Participants will be given conventional therapy only with a 12 menstrual Cycle follow-up.', 'interventionNames': ['Drug: Hormone Replacement Therapy']}], 'interventions': [{'name': 'human umbilical cord mesenchymal stem cells', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Group1 : HRT plus hUCMSCs treatment:']}, {'name': 'hUCMSCs and hCBMNCs', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Group 2: HRT plus hCBMNCs and hUCMSCs therapy']}, {'name': 'human cord blood mononuclear cells', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Group3 : HRT plus hCBMNCs treatment:']}, {'name': 'Hormone Replacement Therapy', 'type': 'DRUG', 'armGroupLabels': ['Group 4:Hormone Replacement Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '518020', 'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fangming Su', 'role': 'CONTACT', 'email': 'sfmlxq@163.com', 'phone': '86-755-25533018'}, {'name': 'Fangming Su', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Shenzhen People's Hospital", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}], 'centralContacts': [{'name': 'FangMing Su, Master', 'role': 'CONTACT', 'email': 'sfmlxq@163.com', 'phone': '86-755-25533018'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenzhen Beike Bio-Technology Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}