NCT01853501

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 15, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

November 6, 2013

Status Verified

November 1, 2013

Enrollment Period

2 years

First QC Date

May 7, 2013

Last Update Submit

November 4, 2013

Conditions

Premature Ovarian Failure

Keywords

POF

Outcome Measures

Primary Outcomes (1)

  • Antral follicle diameter

    Antral follicle diameter were record using transvaginal ultrasound scan.

    within the first 30 weeks (plus or minus 10 weeks) after surgery

Study Arms (1)

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

Autologous fat graftingPROCEDURE

ADSC ovary injection

POF,treatment,ADSC

Eligibility Criteria

Age20 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Drum Tower Hospital of Nanjing University

Nanjing, Jiangsu, 21008, China

Location

Related Publications (5)

  • 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.

    PMID: 22205727BACKGROUND

  • 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.

    PMID: 19878076BACKGROUND

  • 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.

    PMID: 22308860BACKGROUND

  • 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.

    PMID: 20177340BACKGROUND

  • 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.

    PMID: 23212100RESULT

Related Links

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Yali Hu, Ph.D.

    The Affiliated Drum Tower Hospital of Nanjing University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

May 7, 2013

First Posted

May 15, 2013

Study Start

September 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

November 6, 2013

Record last verified: 2013-11

Locations

CN(1)