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

Phase 1

• Conditions: Premature Ovarian Failure，
• Interventions: Drug: Hormone Replacement Therapy; Biological: hUCMSCs and hCBMNCs; Biological: human cord blood mononuclear cells; Biological: human umbilical cord mesenchymal stem cells

• Registration Number: NCT01742533
• Lead Sponsor: Shenzhen Beike Bio-Technology Co., Ltd.

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 Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-11-26
• Status Verified: 2012-12
• Study First Submitted QC: 2012-12-02
• Last Update Submitted: 2012-12-02
• Study First Posted: 2012-12-05
• Last Update Posted: 2012-12-05
• Primary Completion: 2013-06
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 4:Hormone Replacement Therapy	Hormone Replacement Therapy	Participants will be given conventional therapy only with a 12 menstrual Cycle follow-up.
Group 2: HRT plus hCBMNCs and hUCMSCs therapy	hUCMSCs and hCBMNCs	Participants will be given HRT plus combination of hCBMNCs together with hUCMSCs transplantation with a 12 menstrual Cycle follow-up.
Group3 : HRT plus hCBMNCs treatment:	human cord blood mononuclear cells	Participants will be given HRT plus human cord blood mononuclear cells transplantation with a 12 menstrual Cycle follow-up.
Group1 : HRT plus hUCMSCs treatment:	human umbilical cord mesenchymal stem cells	Participants will be given HRT plus human cord mesenchymal stem cells transplantation with a 12 menstrual Cycle follow-up.

Primary Outcome Measures

Name	Time	Method
Serum Level of follicle-stimulating hormone	48 weeks after treatment

Secondary Outcome Measures

Name	Time	Method
Uterine and Ovary characteristics of B ultrasound， including Uterine/Ovarian size and Blood Flow	48 weeks after treatment
Modified Kupperman Score	48 weeks after treatment
Incidence of Adverse Events and Serious Adverse Events	48 weeks after treatment

Trial Locations

Locations (1)

Shenzhen People's Hospital; 🇨🇳 Shenzhen, Guangdong, China