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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group1 : HRT plus hUCMSCs treatment: | Experimental | Participants will be given HRT plus human cord mesenchymal stem cells transplantation with a 12 menstrual Cycle follow-up. |
|
| Group 2: HRT plus hCBMNCs and hUCMSCs therapy | Experimental | 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: | Experimental | Participants will be given HRT plus human cord blood mononuclear cells transplantation with a 12 menstrual Cycle follow-up. |
|
| Group 4:Hormone Replacement Therapy | Experimental | Participants will be given conventional therapy only with a 12 menstrual Cycle follow-up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| human umbilical cord mesenchymal stem cells | Biological |
| ||
| hUCMSCs and hCBMNCs |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Level of follicle-stimulating hormone | 48 weeks after treatment |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| FangMing Su, Master | Contact | 86-755-25533018 | sfmlxq@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen People's Hospital | Recruiting | Shenzhen | Guangdong | 518020 | China |
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| Biological |
|
| human cord blood mononuclear cells | Biological |
|
| Hormone Replacement Therapy | Drug |
|
| Incidence of Adverse Events and Serious Adverse Events |
| 48 weeks after treatment |
| ID | Term |
|---|---|
| D016649 | Primary Ovarian Insufficiency |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D020249 | Hormone Replacement Therapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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