Effects of ADSC Therapy in Women With POF | NCT01853501

Studies
Effects of ADSC Therapy in Women With POF

NCT01853501

Sponsor

Nanjing University

Status

Unknown status

Last Update Posted

Nov 6, 2013Estimated

Enrollment

4Estimated

Phase

Phase 4

Conditions

Premature Ovarian Failure

Interventions

Autologous fat grafting

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Sep 2014Estimated

Completion Date

Sep 2014Estimated

First Submitted Date

May 7, 2013

First Submission Date that Met QC Criteria

May 14, 2013

First Posted Date

May 15, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2013

Last Update Posted Date

Nov 6, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
POF,treatment,ADSC	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Autologous fat grafting	Procedure	ADSC ovary injection	POF,treatment,ADSC

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

39 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yali Hu, Ph.D.	The Affiliated Drum Tower Hospital of Nanjing University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Affiliated Drum Tower Hospital of Nanjing University		Nanjing	Jiangsu	21008	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22205727	Background	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.
19878076	Background	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.

Type	Date	Date Unknown
Release	Oct 23, 2014
Reset	Oct 28, 2014

ID	Term
D010049	Ovarian Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases