NCT02204358

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

Clinical Study of the Treatment of Infertility Caused by Severe Intrauterine Adhesions by Collagen Scaffold Loaded With Autologous Bone Marrow Stem Cells

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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

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

• Infertility
• Intrauterine Adhesions
• Endometrial Dysplasia

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-07-01
• Completion: 2015-12-01
• First posted: 2014-07-30
• Last updated: 2014-07-30

Locations

1 site across 1 country: China