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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
Sponsor:
Information provided by (Responsible Party):
Li-jun Ding, Nanjing University

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.

Condition or disease Intervention/treatment Phase
Premature Ovarian Failure Procedure: Autologous fat grafting Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Procedure: Autologous fat grafting
ADSC ovary injection




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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China, Jiangsu
The Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, China, 21008
Sponsors and Collaborators
Nanjing University
Investigators
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Principal Investigator: Yali Hu, Ph.D. The Affiliated Drum Tower Hospital of Nanjing University

Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Li-jun Ding, lecturer, Nanjing University
ClinicalTrials.gov Identifier: NCT01853501     History of Changes
Other Study ID Numbers: 973 Project No. 2010CB945 104
First Posted: May 15, 2013    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: November 2013

Keywords provided by Li-jun Ding, Nanjing University:
POF

Additional relevant MeSH terms:
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Premature Birth
Primary Ovarian Insufficiency
Menopause, Premature
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases