A Phase 1/2 interventional study of human umbilical cord mesenchymal stem cells and hUCMSCs and hCBMNCs in Premature Ovarian Failure，, sponsored by Shenzhen Beike Bio-Technology Co., Ltd.. Status unknown at 1 site in China. Open to female participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2012-12-05.
Sponsored by Shenzhen Beike Bio-Technology Co., Ltd. · Phase 1/2, Interventional, and Treatment
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.
Premature ovarian failure (POF) is currently managed by non-physiological sex steroid regimens which are inadequate at optimizing uterine characteristics.
Human 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.
In 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.
175 studies on the registry are indexed under Primary Ovarian Insufficiency; 45 are open to participants now.
This study's planned enrollment of 40 is below the median of 49 across 110 interventional studies indexed under Primary Ovarian Insufficiency.
Browse Primary Ovarian Insufficiency studies →Shenzhen Beike Bio-Technology Co., Ltd. is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Participants will be given HRT plus human cord mesenchymal stem cells transplantation with a 12 menstrual Cycle follow-up.
Biological: human umbilical cord mesenchymal stem cells
Participants will be given HRT plus combination of hCBMNCs together with hUCMSCs transplantation with a 12 menstrual Cycle follow-up.
Biological: hUCMSCs and hCBMNCs
Participants will be given HRT plus human cord blood mononuclear cells transplantation with a 12 menstrual Cycle follow-up.
Biological: human cord blood mononuclear cells
Participants will be given conventional therapy only with a 12 menstrual Cycle follow-up.
Drug: Hormone Replacement Therapy
Serum Level of follicle-stimulating hormone
Time frame: 48 weeks after treatment
Uterine and Ovary characteristics of B ultrasound， including Uterine/Ovarian size and Blood Flow
Time frame: 48 weeks after treatment
Modified Kupperman Score
Time frame: 48 weeks after treatment
Incidence of Adverse Events and Serious Adverse Events
Time frame: 48 weeks after treatment
This study is status unknown, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Solizmestrocel
Primary Ovarian Insufficiency →
Shenzhen Beike Bio-Technology Co., Ltd.