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

Beike Biotech

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Premature Ovarian Failure，

Treatments: Biological: human umbilical cord mesenchymal stem cells; Drug: Hormone Replacement Therapy; Biological: hUCMSCs and hCBMNCs; Biological: human cord blood mononuclear cells

Study type: Interventional

Funder types: Industry

Identifiers

NCT01742533

BKCR-POF-1(Ⅰ)

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 4 patient groups

Group1 : HRT plus hUCMSCs treatment:

Experimental group

Description:

Participants will be given HRT plus human cord mesenchymal stem cells transplantation with a 12 menstrual Cycle follow-up.

Treatment:

Biological: human umbilical cord mesenchymal stem cells

Group 2: HRT plus hCBMNCs and hUCMSCs therapy

Experimental group

Description:

Participants will be given HRT plus combination of hCBMNCs together with hUCMSCs transplantation with a 12 menstrual Cycle follow-up.

Treatment:

Biological: hUCMSCs and hCBMNCs

Group3 : HRT plus hCBMNCs treatment:

Experimental group

Description:

Participants will be given HRT plus human cord blood mononuclear cells transplantation with a 12 menstrual Cycle follow-up.

Treatment:

Biological: human cord blood mononuclear cells

Group 4:Hormone Replacement Therapy

Experimental group

Description:

Participants will be given conventional therapy only with a 12 menstrual Cycle follow-up.

Treatment:

Drug: Hormone Replacement Therapy