Treatment of Infertility by Collagen Scaffold Loaded With Autologous Bone Marrow Stem Cells

NCT ID: NCT02204358

Last Updated: 2014-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-12-31

Brief Summary

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Study of the treatment of infertility caused by severe intrauterine adhesions or endometrial dysplasia by collagen scaffold loaded with autologous bone marrow stem cells, and to provide clinical evidence for the treatment of uterine infertility

Detailed Description

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Infertility is defined as a women fails to become pregnant after having a normal sex life for two years without contraception. There is no effective treatment to the infertility caused by severe intrauterine adhesions or endometrial dysplasia which affects embryos implantation. The existing drugs, physical or surgical treatments had no significant effects to severe intrauterine adhesions.Collagen is the main component of the extracellular matrix with good biocompatibility, and it has been approved for the reparation of skin and oral mucosa by State Food and Drug Administration. Bone marrow stem cells have been used in the clinical treatment of blood diseases, and achieved good results. In this study, collagen scaffold and autologous bone marrow stem cells are combined, and they showed good biological safety

Conditions

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Infertility Intrauterine Adhesions Endometrial Dysplasia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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autologous bone marrow stem cells

Using collagen scaffold loaded with autologous bone marrow stem cells to treat severe intrauterine adhesions or endometrial dysplasia.

Group Type EXPERIMENTAL

autologous bone marrow stem cells

Intervention Type PROCEDURE

Before considering whether patients meet the inclusion criteria, they are diagnosed with severe intrauterine adhesions uterus, endometrial dysplasia. And after that there will be history taking, physical examination, chromosome examination, B-ultrasound examination, hysteroscopy examination and so on.

If patients agree to participate, they will receive a bone marrow stem cells collection and separation of adhesions by hysteroscopy surgery. Postoperative observation period is about three months, including B-ultrasound examination once a month and hysteroscopy after 3 months. According to the endometrial conditions, the doctor will select an appropriate time for pregnancy and follow-up. The doctor may also require patients to do some unscheduled visits.

Interventions

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autologous bone marrow stem cells

Before considering whether patients meet the inclusion criteria, they are diagnosed with severe intrauterine adhesions uterus, endometrial dysplasia. And after that there will be history taking, physical examination, chromosome examination, B-ultrasound examination, hysteroscopy examination and so on.

If patients agree to participate, they will receive a bone marrow stem cells collection and separation of adhesions by hysteroscopy surgery. Postoperative observation period is about three months, including B-ultrasound examination once a month and hysteroscopy after 3 months. According to the endometrial conditions, the doctor will select an appropriate time for pregnancy and follow-up. The doctor may also require patients to do some unscheduled visits.

Intervention Type PROCEDURE

Other Intervention Names

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infertility severe intrauterine adhesions endometrial dysplasia collagen scaffold

Eligibility Criteria

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Inclusion Criteria

* Infertility caused by serious intrauterine adhesions or endometrial dysplasia
* Hysteroscopy examination confirmed intrauterine adhesions or endometrial dysplasia
* Monitoring of endometrial cycle
* Sign a consent form
* Follow the test plan and follow-up process

Exclusion Criteria

* Abnormal chromosome karyotype
* Congenital uterine malformations
* Severe endometriosis
* Severe adenomyosis
* Contraindications to pregnancy
* Contraindications to bone marrow collection
* Contraindications to hormone replacement therapy
* Medical history of pelvic tumors or receiving pelvic radiotherapy
* Unable to adhere to the hospital examination and follow-up, or carrying on other treatment during follow-up period
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role lead

Responsible Party

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Yali Hu

MD,PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yali HU, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Vice-president of the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Locations

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Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yali Hu, MD PhD

Role: CONTACT

02583304616 ext. 66808

Facility Contacts

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Yali HU, MD,PhD

Role: primary

02583304616 ext. 66808

Other Identifiers

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2012022

Identifier Type: -

Identifier Source: org_study_id

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