Stem Cell Therapy Combined Hormone Replacement Therapy in Patients With Premature Ovarian Failure
NCT ID: NCT01742533
Last Updated: 2012-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2012-03-31
2014-03-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group1 : HRT plus hUCMSCs treatment:
Participants will be given HRT plus human cord mesenchymal stem cells transplantation with a 12 menstrual Cycle follow-up.
human umbilical cord mesenchymal stem cells
Group 2: HRT plus hCBMNCs and hUCMSCs therapy
Participants will be given HRT plus combination of hCBMNCs together with hUCMSCs transplantation with a 12 menstrual Cycle follow-up.
hUCMSCs and hCBMNCs
Group3 : HRT plus hCBMNCs treatment:
Participants will be given HRT plus human cord blood mononuclear cells transplantation with a 12 menstrual Cycle follow-up.
human cord blood mononuclear cells
Group 4:Hormone Replacement Therapy
Participants will be given conventional therapy only with a 12 menstrual Cycle follow-up.
Hormone Replacement Therapy
Interventions
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human umbilical cord mesenchymal stem cells
hUCMSCs and hCBMNCs
human cord blood mononuclear cells
Hormone Replacement Therapy
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with Premature Ovarian Failure，and currently receiving Hormone Replacement Therapy;
* Willing to sign the Informed Consent Form.
Exclusion Criteria
* 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.
18 Years
39 Years
FEMALE
No
Sponsors
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Shenzhen Beike Bio-Technology Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Shenzhen People's Hospital
Shenzhen, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Fangming Su
Role: primary
Other Identifiers
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BKCR-POF-1(Ⅰ)
Identifier Type: -
Identifier Source: org_study_id