Stem Cell Therapy Combined Hormone Replacement Therapy in Patients With Premature Ovarian Failure

December 2, 2012 updated by: Shenzhen Beike Bio-Technology Co., Ltd.

A Phase Ι/Π Study of Human Cord Blood Mononuclear Cells and Human Umbilical Cord Mesenchymal Stem Cells Transplantation Combined With Hormone Replacement Therapy in Patients With Premature Ovarian Failure

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518020
        • Recruiting
        • ShenZhen People's Hospital
        • Contact:
        • Principal Investigator:
          • Fangming Su

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Enrollment in other trials in the last 3 months. • Other criteria the investigator consider improper for inclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group1 : HRT plus hUCMSCs treatment:
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
Experimental: Group 2: HRT plus hCBMNCs and hUCMSCs therapy
Participants will be given HRT plus combination of hCBMNCs together with hUCMSCs transplantation with a 12 menstrual Cycle follow-up.
Biological: hUCMSCs and hCBMNCs
Experimental: Group3 : HRT plus hCBMNCs treatment:
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
Experimental: Group 4:Hormone Replacement Therapy
Participants will be given conventional therapy only with a 12 menstrual Cycle follow-up.
Drug: Hormone Replacement Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum Level of follicle-stimulating hormone
Time Frame: 48 weeks after treatment
48 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Uterine and Ovary characteristics of B ultrasound， including Uterine/Ovarian size and Blood Flow
Time Frame: 48 weeks after treatment
48 weeks after treatment
Modified Kupperman Score
Time Frame: 48 weeks after treatment
48 weeks after treatment
Incidence of Adverse Events and Serious Adverse Events
Time Frame: 48 weeks after treatment
48 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen Beike Bio-Technology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

March 1, 2014

Study Registration Dates

First Submitted

November 26, 2012

First Submitted That Met QC Criteria

December 2, 2012

First Posted (Estimate)

December 5, 2012

Study Record Updates

Last Update Posted (Estimate)

December 5, 2012

Last Update Submitted That Met QC Criteria

December 2, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BKCR-POF-1(Ⅰ)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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