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

• Status: Unknown status
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shenzhen Beike Bio-Technology Co., Ltd.
• Treatments: Hormones

Criteria

Inclusion Criteria:

• Between age 18- 39 years, Female only.

• Diagnosed with Premature Ovarian Failure，and currently receiving Hormone Replacement Therapy;

• Willing to sign the Informed Consent Form.

Exclusion Criteria:

• Fragile X chromosome.

• polycystic ovary syndrome.

• HIV+.

• Autoimmune disease, e.g. lupus erythematosus, multiple sclerosis.

• Severe pulmonary and hematological disease, malignancy or hypo-immunity.

• Currently undertaking other treatment that may affect the safety/efficacy of stem cells.

• Pregnancy or lactation

• Enrollment in other trials in the last 3 months. • Other criteria the investigator consider improper for inclusion.