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

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01742533

Enrollment

Registered

2012-12-05

Start date

2012-03-31

Completion date

2014-03-31

Last updated

2012-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Ovarian Failure，

Keywords

Hormone Replacement Therapy，, Premature Ovarian Failure，, Stem Cell Therapy

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.

Interventions

BIOLOGICALhuman umbilical cord mesenchymal stem cells

BIOLOGICALhUCMSCs and hCBMNCs

BIOLOGICALhuman cord blood mononuclear cells

DRUGHormone Replacement Therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 39 Years

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.

Design outcomes

Primary

Measure	Time frame
Serum Level of follicle-stimulating hormone	48 weeks after treatment

Secondary

Measure	Time frame
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

Countries

China

Contacts

Primary ContactFangMing Su, Master

sfmlxq@163.com86-755-25533018

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026