Effects of ADSC Therapy in Women With POF

Phase 4

• Conditions: Premature Ovarian Failure
• Interventions: Procedure: Autologous fat grafting

• Registration Number: NCT01853501
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-05-07
• Study First Submitted QC: 2013-05-14
• Study First Posted: 2013-05-15
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-04
• Last Update Posted: 2013-11-06
• Primary Completion: 2014-09
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
POF,treatment,ADSC	Autologous fat grafting	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.

Primary Outcome Measures

Name	Time	Method
Antral follicle diameter	within the first 30 weeks (plus or minus 10 weeks) after surgery	Antral follicle diameter were record using transvaginal ultrasound scan.

Trial Locations

Locations (1)

The Affiliated Drum Tower Hospital of Nanjing University; 🇨🇳 Nanjing, Jiangsu, China