Premature Ovarian Failure, Clinical Trial
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 Premature Ovarian Failure
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.
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | March 2014 |
| Est. primary completion date | June 2013 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 39 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Shenzhen People's Hospital | Shenzhen | Guangdong |
| Lead Sponsor | Collaborator |
|---|---|
| Shenzhen Beike Bio-Technology Co., Ltd. |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Serum Level of follicle-stimulating hormone | 48 weeks after treatment | No | |
| Secondary | Uterine and Ovary characteristics of B ultrasound, including Uterine/Ovarian size and Blood Flow | 48 weeks after treatment | No | |
| Secondary | Modified Kupperman Score | 48 weeks after treatment | No | |
| Secondary | Incidence of Adverse Events and Serious Adverse Events | 48 weeks after treatment | Yes |