Text Size

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

This study is currently recruiting participants.
Verified December 2012 by Shenzhen Beike Bio-Technology Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Shenzhen Beike Bio-Technology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01742533
First received: November 26, 2012
Last updated: December 2, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Premature Ovarian Failure，
 Biological: human umbilical cord mesenchymal stem cells
Biological: hUCMSCs and hCBMNCs
Biological: human cord blood mononuclear cells
Drug: Hormone Replacement Therapy
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shenzhen Beike Bio-Technology Co., Ltd.:

Primary Outcome Measures:
  • Serum Level of follicle-stimulating hormone [ Time Frame: 48 weeks after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Uterine and Ovary characteristics of B ultrasound， including Uterine/Ovarian size and Blood Flow [ Time Frame: 48 weeks after treatment ] [ Designated as safety issue: No ]
  • Modified Kupperman Score [ Time Frame: 48 weeks after treatment ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events and Serious Adverse Events [ Time Frame: 48 weeks after treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: March 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01742533

Contacts
Contact: FangMing Su, Master 86-755-25533018 sfmlxq@163.com

Locations
China, Guangdong
Shenzhen People's Hospital Recruiting
Shenzhen, Guangdong, China, 518020
Contact: Fangming Su     86-755-25533018     sfmlxq@163.com    
Principal Investigator: Fangming Su            
Sponsors and Collaborators
Shenzhen Beike Bio-Technology Co., Ltd.
  More Information

No publications provided

Responsible Party: Shenzhen Beike Bio-Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT01742533     History of Changes
Other Study ID Numbers: BKCR-POF-1(Ⅰ)
Study First Received: November 26, 2012
Last Updated: December 2, 2012
Health Authority: China: Ministry of Health

Keywords provided by Shenzhen Beike Bio-Technology Co., Ltd.:
Hormone Replacement Therapy，
Premature Ovarian Failure，
Stem Cell Therapy

Additional relevant MeSH terms:
Menopause, Premature
Primary Ovarian Insufficiency
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
 Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013