Effects of ADSC Therapy in Women With POF

November 4, 2013 updated by: Li-jun Ding, Nanjing University

Effects of Adipose Derived Stem Cell Therapy in Women With Premature Ovarian Failure

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

4

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 21008
        • The Affiliated Drum Tower Hospital of Nanjing University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 39 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within the first 30 weeks (plus or minus 10 weeks) after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing University

Investigators

  • Principal Investigator: Yali Hu, Ph.D., The Affiliated Drum Tower Hospital of Nanjing University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ANTICIPATED)

September 1, 2014

Study Completion (ANTICIPATED)

September 1, 2014

Study Registration Dates

First Submitted

May 7, 2013

First Submitted That Met QC Criteria

May 14, 2013

First Posted (ESTIMATE)

May 15, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 6, 2013

Last Update Submitted That Met QC Criteria

November 4, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 973 Project No. 2010CB945 104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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