NCT02644447

Brief Summary

Cellular therapies are rapidly progressing fields and have shown immense promise in the treatment of damaged ovarian function. The purpose of this study is to determine safety and efficacy of intra-ovarian injection of allogeneic HUC-MSCs with injectable collagen scaffold in women with Premature Ovarian Failure (POF) and to study the preliminary efficacy of HUC-MSCs with injectable collagen scaffold injection on ovarian function improvement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 31, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

January 13, 2020

Status Verified

December 1, 2015

Enrollment Period

3 years

First QC Date

December 28, 2015

Last Update Submit

January 9, 2020

Conditions

Premature Ovarian Failure

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability assessed by Adverse Events

    Proportion of patients with postoperative infections and serious adverse events (SAEs) were assessed by long term follow-up.

    Up to 6 months

Secondary Outcomes (5)

  • Number of Antral follicle development

    Once a week within 3 months after the surgery

  • Estradiol (E2) serum level

    Once a week within 3 months after the surgery

  • Follicle Stimulating Hormone (FSH) serum level

    Once a week within 3 months after the surgery

  • Anti-Mullerian Hormone (AMH) serum level

    Once a week within 3 months after the surgery

  • Pregnancy rate

    2 weeks after embryo implantation

Study Arms (2)

HUC-MSCs Transplantation

EXPERIMENTAL
Biological: HUC-MSCs Transplantation

HUC-MSCs with Injectable Collagen Scaffold Transplantation

EXPERIMENTAL
Biological: HUC-MSCs with Injectable Collagen Scaffold Transplantation

Interventions

HUC-MSCs TransplantationBIOLOGICAL

The patients with POF that will undergo bilateral ovaries injection of 10 million allogeneic HUC-MSCs.

HUC-MSCs Transplantation
HUC-MSCs with Injectable Collagen Scaffold TransplantationBIOLOGICAL

The patients with POF that will undergo bilateral ovaries injection of 10 million allogeneic HUC-MSCs with injectable collagen scaffold.

HUC-MSCs with Injectable Collagen Scaffold Transplantation

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with Premature Ovarian Failure.
  • Patients show no response to drug treatment
  • Women between 20 and 39 years.
  • Willing to sign the Informed Consent Form.

You may not qualify if:

  • Abnormal karyotyping (e.g. turner syndrome, fragile X syndrome).
  • Congenital ovarian malformation.
  • Severe endometriosis.
  • Thyroid dysfunction.
  • Contraindications for pregnancy.
  • Contraindications for hormone replacement therapy.
  • Prior personal history of ovarian cancer or after radiotherapy.
  • Unwilling to comply with follow-up schedule or want to take other treatment during the follow-up period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

Location

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

  • Jianwu Dai, Ph.D

    Chinese Academy of Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS

Study Record Dates

First Submitted

December 28, 2015

First Posted

December 31, 2015

Study Start

October 1, 2015

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

January 13, 2020

Record last verified: 2015-12

Locations

CN(1)