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| Name | Class |
|---|---|
| Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China | INDUSTRY |
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This project aims to investigate the safety and effectiveness of human amniotic epithelial cells in the treatment of the severe refractory Asherman's syndrome.
Asherman's syndrome is a gynecological disorder caused by the destruction of the endometrium due to repeated or aggressive curettages and/or endometritis. As a result, there is a loss of functional endometrium in multiple areas and the uterine cavity is obliterated by intrauterine adhesions, which results in amenorrhea, hypomenorrhea, infertility and recurrent pregnancy loss. Transcervical resection of adhesion (TCRA) is the main treatment for Asherman's syndrome, so far the effect is usually poor in moderate to severe refractory cases.
Human amniotic epithelial cells (hAECs) are derived from human amniotic epithelium. hAECs retain the characteristics approximating to embryonic stem cells. Animal experiments have shown that the endometrial thickness and fertility of mice were significantly improved after intrauterine therapy with amniotic epithelial cells. To further explore the role of hAECs in Asherman's syndrome patients, this project plans to evaluate the safety of hAECs provided by Chongqing iCELL Biotechnology Co.,Ltd., which is a subsidiary of Shanghai iCELL Biotechnology Co.,Ltd., and find an effective treatment protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| biological amnion loaded with hAECs | Experimental | Biological amnion loaded with 100 million hAECs is placed into uterine cavity immediately after TCRA. |
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| biological amnion | Placebo Comparator | Biological amnion is placed into uterine cavity immediately after TCRA. |
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| intravenous infusion of hAECs | Experimental | intravenous infusion of 100 million hAECs immediately after TCRA |
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| intrauterine infusion of hAECs | Experimental | 100 million hAECs is infused into uterine cavity immediately after TCRA. |
|
| hydrogel loaded with hAECs | Experimental | Hydrogel loaded with 100 million hAECs is infused into uterine cavity immediately after TCRA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hAECs | Biological | hAECs are provided by Chongqing iCELL Biotechnology Co.,Ltd., which is a subsidiary of Shanghai iCELL Biotechnology Co.,Ltd. The participants are blind to their arms because the surgery is done under anesthesia. After hysteroscopic adhesiolysis, subsequently oral antibiotics will be given for 3 days to prevent infection. Estrogen will be administrated for 3 cycles to stimulate the repair of endometrium after the surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Menstrual blood volume | Estimate the menstrual blood volume after surgery by the number of sanitary napkins per day and number of days, which will be compared with pre-operation. | at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Endometrial thickness | Measure the endometrial thickness during periovulatory period on ultrasound by the same trained medical sonographers at 3 months after surgery, compared with pre-operation. | at 3 months |
| Uterine volume |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lina Hu | Contact | 86-23-63693707 | cqhulina@126.com | |
| Chanyu Zhang | Contact | 86-23-63693296 | 1317954623@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Lina Hu | The Second Affiliated Hospital of Chongqing Medical University | Study Chair |
| Chanyu Zhang | The Second Affiliated Hospital of Chongqing Medical University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18406834 | Background | Yu D, Wong YM, Cheong Y, Xia E, Li TC. Asherman syndrome--one century later. Fertil Steril. 2008 Apr;89(4):759-79. doi: 10.1016/j.fertnstert.2008.02.096. | |
| 18995896 | Background | Ilancheran S, Moodley Y, Manuelpillai U. Human fetal membranes: a source of stem cells for tissue regeneration and repair? Placenta. 2009 Jan;30(1):2-10. doi: 10.1016/j.placenta.2008.09.009. Epub 2008 Nov 7. |
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| ID | Term |
|---|---|
| D006175 | Gynatresia |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| biological amnion | Biological | Biological amnion is purchased from JiangXi RuiJi BioTechnology Co.,Ltd. The participants are blind to their arms because the surgery is done under anesthesia. After hysteroscopic adhesiolysis, subsequently oral antibiotics will be given for 3 days to prevent infection. Estrogen will be administrated for 3 cycles to stimulate the repair of endometrium after the surgery. |
|
Measure the uterine volume during periovulatory period on ultrasound by the same trained medical sonographers at 3 months after surgery, compared with pre-operation.
| at 3 months |
| Ongoing pregnancy rate | A ongoing pregnancy means that at the 12th week of pregnancy, ultrasound reveals that the fetus had a heart beat and the size of the fetus is in consistent with the gestational week. | up to 24 months |
| Fan He |
| The Second Affiliated Hospital of Chongqing Medical University |
| Principal Investigator |
| Jianguo Hu | The Second Affiliated Hospital of Chongqing Medical University | Principal Investigator |
| Heng Zou | The Second Affiliated Hospital of Chongqing Medical University | Principal Investigator |
| Huijia Chen | The Second Affiliated Hospital of Chongqing Medical University | Principal Investigator |
| D000091662 | Genital Diseases |