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Effects of ADSC Therapy in Women With POF

NCT ID: NCT01853501

Last Updated: 2013-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-09-30

Brief Summary

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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

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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.

Conditions

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Premature Ovarian Failure

Keywords

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POF

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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POF,treatment,ADSC

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.

Group Type EXPERIMENTAL

Autologous fat grafting

Intervention Type PROCEDURE

ADSC ovary injection

Interventions

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Autologous fat grafting

ADSC ovary injection

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Nanjing University

OTHER

Sponsor Role lead

Responsible Party

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Li-jun Ding

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yali Hu, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Drum Tower Hospital of Nanjing University

Locations

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The Affiliated Drum Tower Hospital of Nanjing University

Nanjing, Jiangsu, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 22205727 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19878076 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22308860 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20177340 (View on PubMed)

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.

Reference Type RESULT
PMID: 23212100 (View on PubMed)

Related Links

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http://www.ivf-gl.com/

IVF center website

Other Identifiers

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973 Project No. 2010CB945 104

Identifier Type: -

Identifier Source: org_study_id