Stem Cell Therapy Combined Hormone Replacement Therapy in Patients With Premature Ovarian Failure
Recruitment status was: Recruiting
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.
|Premature Ovarian Failure，||Biological: human umbilical cord mesenchymal stem cells Biological: hUCMSCs and hCBMNCs Biological: human cord blood mononuclear cells Drug: Hormone Replacement Therapy||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- 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 ]
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: Group1 : HRT plus hUCMSCs treatment:
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|
Experimental: Group 2: HRT plus hCBMNCs and hUCMSCs therapy
Participants will be given HRT plus combination of hCBMNCs together with hUCMSCs transplantation with a 12 menstrual Cycle follow-up.
|Biological: hUCMSCs and hCBMNCs|
Experimental: Group3 : HRT plus hCBMNCs treatment:
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|
Experimental: Group 4:Hormone Replacement Therapy
Participants will be given conventional therapy only with a 12 menstrual Cycle follow-up.
|Drug: Hormone Replacement Therapy|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01742533
|Contact: FangMing Su, Masterfirstname.lastname@example.org|
|Shenzhen People's Hospital||Recruiting|
|Shenzhen, Guangdong, China, 518020|
|Contact: Fangming Su 86-755-25533018 email@example.com|
|Principal Investigator: Fangming Su|