Transplantation of HUC-MSCs With Injectable Collagen Scaffold for POF
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|ClinicalTrials.gov Identifier: NCT02644447|
Recruitment Status : Unknown
Verified December 2015 by Jianwu Dai, Chinese Academy of Sciences.
Recruitment status was: Active, not recruiting
First Posted : December 31, 2015
Last Update Posted : July 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Premature Ovarian Failure||Biological: HUC-MSCs Transplantation Biological: HUC-MSCs with Injectable Collagen Scaffold Transplantation||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||The Safety and Efficacy Assessment of Human Umbilical Cord-derived Mesenchymal Stem Cells (HUC-MSCs) With Injectable Collagen Scaffold Transplantation in Woman With Premature Ovarian Failure (POF)|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2018|
|Experimental: HUC-MSCs Transplantation||
Biological: HUC-MSCs Transplantation
The patients with POF that will undergo bilateral ovaries injection of 10 million allogeneic HUC-MSCs.
|Experimental: HUC-MSCs with Injectable Collagen Scaffold Transplantation||
Biological: HUC-MSCs with Injectable Collagen Scaffold Transplantation
The patients with POF that will undergo bilateral ovaries injection of 10 million allogeneic HUC-MSCs with injectable collagen scaffold.
- Safety and Tolerability assessed by Adverse Events [ Time Frame: Up to 6 months ]Proportion of patients with postoperative infections and serious adverse events (SAEs) were assessed by long term follow-up.
- Number of Antral follicle development [ Time Frame: Once a week within 3 months after the surgery ]The number of follicles developing was recorded by transvaginal ultrasound scan.
- Estradiol (E2) serum level [ Time Frame: Once a week within 3 months after the surgery ]Serum E2 level was evaluated after surgery.
- Follicle Stimulating Hormone (FSH) serum level [ Time Frame: Once a week within 3 months after the surgery ]Serum FSH level was evaluated after surgery.
- Anti-Mullerian Hormone (AMH) serum level [ Time Frame: Once a week within 3 months after the surgery ]Serum AMH level was evelated after surgery.
- Pregnancy rate [ Time Frame: 2 weeks after embryo implantation ]The incidence of pregnancy following transfer of embryos produced from oocytes recovered from follicles developing was assessed by Serum Human Chorionic Gonadotropin (HCG) detection.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02644447
|The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School|
|Nanjing, Jiangsu, China, 210008|
|Principal Investigator:||Jianwu Dai, Ph.D||Chinese Academy of Sciences|