Effects of ADSC Therapy in Women With POF
Primary Purpose
Premature Ovarian Failure
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Autologous fat grafting
Sponsored by
About this trial
This is an interventional treatment trial for Premature Ovarian Failure focused on measuring POF
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
Sites / Locations
- The Affiliated Drum Tower Hospital of Nanjing University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
POF,treatment,ADSC
Arm Description
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.
Outcomes
Primary Outcome Measures
Antral follicle diameter
Antral follicle diameter were record using transvaginal ultrasound scan.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01853501
Brief Title
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
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
September 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ovarian Failure
Keywords
POF
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
POF,treatment,ADSC
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Autologous fat grafting
Intervention Description
ADSC ovary injection
Primary Outcome Measure Information:
Title
Antral follicle diameter
Description
Antral follicle diameter were record using transvaginal ultrasound scan.
Time Frame
within the first 30 weeks (plus or minus 10 weeks) after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yali Hu, Ph.D.
Organizational Affiliation
The Affiliated Drum Tower Hospital of Nanjing University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Affiliated Drum Tower Hospital of Nanjing University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
21008
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
22205727
Citation
Silber SJ. Ovary cryopreservation and transplantation for fertility preservation. Mol Hum Reprod. 2012 Feb;18(2):59-67. doi: 10.1093/molehr/gar082. Epub 2011 Dec 28.
Results Reference
background
PubMed Identifier
19878076
Citation
Lin G, Wang G, Banie L, Ning H, Shindel AW, Fandel TM, Lue TF, Lin CS. Treatment of stress urinary incontinence with adipose tissue-derived stem cells. Cytotherapy. 2010;12(1):88-95. doi: 10.3109/14653240903350265.
Results Reference
background
PubMed Identifier
22308860
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.
Results Reference
background
PubMed Identifier
20177340
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.
Results Reference
background
PubMed Identifier
23212100
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.
Results Reference
result
Links:
URL
http://www.ivf-gl.com/
Description
IVF center website
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Effects of ADSC Therapy in Women With POF
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