NCT01742533

Brief Summary

Premature ovarian failure (POF) refers the occurrence of amenorrhoea, elevated serum gonadotrophins and hypoestrogenism levels in female before the age of 40. It has important physical and psychological consequences/impact in those patients. Premature ovarian failure (POF) is currently managed by non-physiological sex steroid regimens which are inadequate at optimizing uterine characteristics. Human umbilical cord mesenchymal stem cells (hUCMSCs) and human cord blood mononuclear cells (hCBMNCs) have been shown to have the ability to modulate the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy for POF. In this study, the safety and efficacy of hUCMSCs and hCBMNCs transplantation combined with Hormone Replacement Therapy will be evaluated in patients with Premature Ovarian Failure. Participants will be followed for an expected average of 48 weeks.

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
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2012

Typical duration for phase_1

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

March 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 5, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

December 5, 2012

Status Verified

December 1, 2012

Enrollment Period

1.3 years

First QC Date

November 26, 2012

Last Update Submit

December 2, 2012

Conditions

Premature Ovarian Failure，

Keywords

Hormone Replacement Therapy，Premature Ovarian Failure，Stem Cell Therapy

Outcome Measures

Primary Outcomes (1)

  • Serum Level of follicle-stimulating hormone

    48 weeks after treatment

Secondary Outcomes (3)

  • Uterine and Ovary characteristics of B ultrasound， including Uterine/Ovarian size and Blood Flow

    48 weeks after treatment

  • Modified Kupperman Score

    48 weeks after treatment

  • Incidence of Adverse Events and Serious Adverse Events

    48 weeks after treatment

Study Arms (4)

Group1 : HRT plus hUCMSCs treatment:

EXPERIMENTAL

Participants will be given HRT plus human cord mesenchymal stem cells transplantation with a 12 menstrual Cycle follow-up.

Biological: human umbilical cord mesenchymal stem cells

Group 2: HRT plus hCBMNCs and hUCMSCs therapy

EXPERIMENTAL

Participants will be given HRT plus combination of hCBMNCs together with hUCMSCs transplantation with a 12 menstrual Cycle follow-up.

Biological: hUCMSCs and hCBMNCs

Group3 : HRT plus hCBMNCs treatment:

EXPERIMENTAL

Participants will be given HRT plus human cord blood mononuclear cells transplantation with a 12 menstrual Cycle follow-up.

Biological: human cord blood mononuclear cells

Group 4:Hormone Replacement Therapy

EXPERIMENTAL

Participants will be given conventional therapy only with a 12 menstrual Cycle follow-up.

Drug: Hormone Replacement Therapy

Interventions

human umbilical cord mesenchymal stem cellsBIOLOGICAL
Group1 : HRT plus hUCMSCs treatment:
hUCMSCs and hCBMNCsBIOLOGICAL
Group 2: HRT plus hCBMNCs and hUCMSCs therapy
human cord blood mononuclear cellsBIOLOGICAL
Group3 : HRT plus hCBMNCs treatment:
Hormone Replacement TherapyDRUG
Group 4:Hormone Replacement Therapy

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Between age 18- 39 years, Female only.
  • Diagnosed with Premature Ovarian Failure，and currently receiving Hormone Replacement Therapy;
  • Willing to sign the Informed Consent Form.

You may not qualify if:

  • Fragile X chromosome.
  • polycystic ovary syndrome.
  • HIV+.
  • Autoimmune disease, e.g. lupus erythematosus, multiple sclerosis.
  • Severe pulmonary and hematological disease, malignancy or hypo-immunity.
  • Currently undertaking other treatment that may affect the safety/efficacy of stem cells.
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen People's Hospital

Shenzhen, Guangdong, 518020, China

RECRUITING

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Interventions

Hormone Replacement Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Central Study Contacts

FangMing Su, Master

CONTACT

86-755-25533018sfmlxq@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2012

First Posted

December 5, 2012

Study Start

March 1, 2012

Primary Completion

June 1, 2013

Study Completion

March 1, 2014

Last Updated

December 5, 2012

Record last verified: 2012-12

Locations

CN(1)