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

Nanjing University

Status and phase: Unknown; Phase 4

Conditions: Endometrial Dysplasia; Infertility; Intrauterine Adhesions

Treatments: Procedure: autologous bone marrow stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT02204358

2012022

Details and patient eligibility

About

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

Full description

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

Enrollment: 30 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

autologous bone marrow stem cells

Experimental group

Description:

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

Treatment:

Procedure: autologous bone marrow stem cells