search
Back to results

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

Primary Purpose

Premature Ovarian Failure，

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
human umbilical cord mesenchymal stem cells
hUCMSCs and hCBMNCs
human cord blood mononuclear cells
Hormone Replacement Therapy
Sponsored by
Shenzhen Beike Bio-Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Ovarian Failure， focused on measuring Hormone Replacement Therapy，, Premature Ovarian Failure，, Stem Cell Therapy

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Shenzhen People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group1 : HRT plus hUCMSCs treatment:

Group 2: HRT plus hCBMNCs and hUCMSCs therapy

Group3 : HRT plus hCBMNCs treatment:

Group 4:Hormone Replacement Therapy

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Serum Level of follicle-stimulating hormone

Secondary Outcome Measures

Uterine and Ovary characteristics of B ultrasound， including Uterine/Ovarian size and Blood Flow
Modified Kupperman Score
Incidence of Adverse Events and Serious Adverse Events

Full Information

First Posted
November 26, 2012
Last Updated
December 2, 2012
Sponsor
Shenzhen Beike Bio-Technology Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT01742533
Brief Title
Stem Cell Therapy Combined Hormone Replacement Therapy in Patients With Premature Ovarian Failure
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Beike Bio-Technology Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ovarian Failure，
Keywords
Hormone Replacement Therapy，, Premature Ovarian Failure，, Stem Cell Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group1 : HRT plus hUCMSCs treatment:
Arm Type
Experimental
Arm Description
Participants will be given HRT plus human cord mesenchymal stem cells transplantation with a 12 menstrual Cycle follow-up.
Arm Title
Group 2: HRT plus hCBMNCs and hUCMSCs therapy
Arm Type
Experimental
Arm Description
Participants will be given HRT plus combination of hCBMNCs together with hUCMSCs transplantation with a 12 menstrual Cycle follow-up.
Arm Title
Group3 : HRT plus hCBMNCs treatment:
Arm Type
Experimental
Arm Description
Participants will be given HRT plus human cord blood mononuclear cells transplantation with a 12 menstrual Cycle follow-up.
Arm Title
Group 4:Hormone Replacement Therapy
Arm Type
Experimental
Arm Description
Participants will be given conventional therapy only with a 12 menstrual Cycle follow-up.
Intervention Type
Biological
Intervention Name(s)
human umbilical cord mesenchymal stem cells
Intervention Type
Biological
Intervention Name(s)
hUCMSCs and hCBMNCs
Intervention Type
Biological
Intervention Name(s)
human cord blood mononuclear cells
Intervention Type
Drug
Intervention Name(s)
Hormone Replacement Therapy
Primary Outcome Measure Information:
Title
Serum Level of follicle-stimulating hormone
Time Frame
48 weeks after treatment
Secondary Outcome Measure Information:
Title
Uterine and Ovary characteristics of B ultrasound， including Uterine/Ovarian size and Blood Flow
Time Frame
48 weeks after treatment
Title
Modified Kupperman Score
Time Frame
48 weeks after treatment
Title
Incidence of Adverse Events and Serious Adverse Events
Time Frame
48 weeks after treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
FangMing Su, Master
Phone
86-755-25533018
Email
sfmlxq@163.com
Facility Information:
Facility Name
Shenzhen People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fangming Su
Phone
86-755-25533018
Email
sfmlxq@163.com
First Name & Middle Initial & Last Name & Degree
Fangming Su

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs