Effects of ADSC Therapy in Women With POF
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|ClinicalTrials.gov Identifier: NCT01853501|
Recruitment Status : Unknown
Verified November 2013 by Li-jun Ding, Nanjing University.
Recruitment status was: Enrolling by invitation
First Posted : May 15, 2013
Last Update Posted : November 6, 2013
|Condition or disease||Intervention/treatment||Phase|
|Premature Ovarian Failure||Procedure: Autologous fat grafting||Phase 4|
The purpose of this study was to explore the therapeutic potency of the adipose derived stem cells (ADSC) transplantation for premature ovarian failure (POF) women underwent Autologous fat transplantation. The serum of each patient were kept and sent for laboratory test before the surgery. 100ml fat was harvested from the abdomen of POF patient using abdominal fat abortion. And ADSC were isolated and cultured in vitro using autologous serum. The biomarkers of ADSC, CD29 and CD44, were detected in the ADSC cultures using Flow cytometry detection. The ADSC were then transplanted directly into bilateral ovaries when cells reach a density of 5-10×106. The clinical conditions of patients were examined at 1, 2, 4 and 8 weeks after the transplantation. Ovarian functions were evaluated by follicle diameter and sexual hormone levels. The follicle number was counted and radiology data were kept for future analysis. To ensure high rate of pregnancy, intercourse under medical guidance may be suggested and hormone replacement treatment may be taken to help the patients conceive.
Main Outcome Measure(s): Serum FSH,LH,E2 levels, recurrence of Menstruation, Antral follicle diameter,and pregnancy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Adipose Derived Stem Cell Therapy in Women With Premature Ovarian Failure|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||September 2014|
|Estimated Study Completion Date :||September 2014|
Fat from POF patients undergo Autologous fat grafting operation were separated, from which Adipose Derived Stem Cell were then purified and injected into the both ovaries of patients.
Procedure: Autologous fat grafting
ADSC ovary injection
- Antral follicle diameter [ Time Frame: within the first 30 weeks (plus or minus 10 weeks) after surgery ]Antral follicle diameter were record using transvaginal ultrasound scan.
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): NCT01853501
|The Affiliated Drum Tower Hospital of Nanjing University|
|Nanjing, Jiangsu, China, 21008|
|Principal Investigator:||Yali Hu, Ph.D.||The Affiliated Drum Tower Hospital of Nanjing University|