Clinical Trial: Stem Cell Therapy Combined Hormone Replacement Therapy in Patients With Premature Ovarian Failure

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary:
Sponsor: Shenzhen Beike Bio-Technology Co., Ltd.

Current Primary Outcome: Serum Level of follicle-stimulating hormone [ Time Frame: 48 weeks after treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Shenzhen Beike Bio-Technology Co., Ltd.

Dates:
Date Received: November 26, 2012
Date Started: March 2012
Date Completion: March 2014
Last Updated: December 2, 2012
Last Verified: December 2012