Clinical trial NCT01853501: Effects of ADSC Therapy in Women With POF
Official title: Effects of Adipose Derived Stem Cell Therapy in Women With Premature Ovarian Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Premature Ovarian Failure
Keywords: POF
Lead sponsor: Nanjing University
Sponsor class: OTHER
First posted: 2013-05-15
Enrollment: 4
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Adipose Derived Stem Cells are effective in the treatment of Premature Ovarian Failure (POF). Stem cell transplantation has been reported to rescue ovarian function in a pre-clinical mouse model of chemotherapy-induced POF; however, maintaining the survival of transplanted cells in human ovarian tissues to enable the POF patients regain ovary function over the long-term and achieving a successful pregnancy remain a troublesome issue. In this study the investigators are aiming to determine whether the CD29+/CD44+ human Adipose Derived Stem Cells could later enable ovaries produce mature oocytes.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Premature Ovarian Failure
* Patients show no response to drug treatment
* Willing to receive follow up
* Willing to conceive a baby
* Age between 20 to 39

Exclusion Criteria:

* Patients with few abdominal fat
* Patients with chromosome abnormalities
* Patients with congenital ovarian malformations
* Patients with severe endometriosis
* Patients with thyroid dysfunction
* Patients with pregnancy contraindications
* Patients with hormone replacement therapy contraindications
* Patients with liposuction contraindications
* Past history of ovarian tumors or after radiotherapy
* Can not take the follow-up, or want to take other treatment during the follow-up period
* Patients with immune system diseases

Primary outcomes:
measure: Antral follicle diameter
timeFrame: within the first 30 weeks (plus or minus 10 weeks) after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Affiliated Drum Tower Hospital of Nanjing University
state: Jiangsu
Study officials:
affiliation: The Affiliated Drum Tower Hospital of Nanjing University
name: Yali Hu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Cho WK, Lee JW, Chung NG, Jung MH, Cho B, Suh BK, Kim HK. Primary ovarian dysfunction after hematopoietic stem cell transplantation during childhood: busulfan-based conditioning is a major concern. J Pediatr Endocrinol Metab. 2011;24(11-12):1031-5. doi: 10.1515/jpem.2011.339.
citation: Feng W, Cui Y, Zhan H, Shi M, Cui W, Guo K, Li Q, Song C, Zhang Y, Mori T, Gershwin ME, Abraham NG, Ikehara S. Prevention of premature ovarian failure and osteoporosis induced by irradiation using allogeneic ovarian/bone marrow transplantation. Transplantation. 2010 Feb 27;89(4):395-401. doi: 10.1097/TP.0b013e3181ca86bb.
citation: Takehara Y, Yabuuchi A, Ezoe K, Kuroda T, Yamadera R, Sano C, Murata N, Aida T, Nakama K, Aono F, Aoyama N, Kato K, Kato O. The restorative effects of adipose-derived mesenchymal stem cells on damaged ovarian function. Lab Invest. 2013 Feb;93(2):181-93. doi: 10.1038/labinvest.2012.167. Epub 2012 Nov 19.