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The Clinical Trial Study of Bone Marrow Stem Cells Through Uterine Artery for Repairing Endometrium with Severe Intrauterine Adhesion

The Clinical Trial Study of Bone Marrow Stem Cells Through Uterine Artery for Repairing Endometrium with Severe Intrauterine Adhesion

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062519
Enrollment
Unknown
Registered
2022-08-10
Start date
2020-07-10
Completion date
Unknown
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrauterine adhesions

Interventions

Stem cell intervention group:Hormone replacement therapy + Interventional perfusion of stem cells via uterine artery
control group:Hormone replacement therapy only

Sponsors

The Sixth Affiliated Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 38 Years

Inclusion criteria

Inclusion criteria: 1. Fully understand the purpose of the study and fully understand and sign the protocol; 2. The age of the subjects was 20-38 years old; 3. Body mass index (BMI) was 18-27 kg / m^2; 4. Regular menstrual cycle in at least half a year, 27-35 days; 5. Ovarian reserve was normal, AFC >= 6, serum follicle stimulating hormone (FSH) level was 1-10iu / L on day 2-4 of menstrual cycle, and other basic sex hormone indexes were within the normal range of clinical laboratory; 6. Within half a year, HIV antibody, TPPA, HBsAg and HCV Ag were negative; 7. According to Gardner's blastocyst grading standard, the number of D5 / D6 blastocysts was more than 2; 8. The previous diagnosis of severe intrauterine adhesions by hysteroscopy had been performed with electric resection. The shape of uterine cavity was basically normal within 3 months; 9. The history of frozen embryo transfer (endometrial thickness < 6 mm in HRT cycle or / and natural cycle) was cancelled due to repeated monitoring of endometrial thinness and adverse reaction by B-ultrasound.

Exclusion criteria

Exclusion criteria: 1. Patients with ovarian cyst diameter >= 20 mm, submucous myoma or intramural myoma > 30 mm, pituitary tumor and malignant tumor of various tissues and organs; 2. Patients with the abnormal uterus (endometrial polyps, intrauterine adhesions, uterine malformations, endometriosis) and adnexa (hydrosalpinx) with clinical significance; 3. Failure of repeated implantation, such as three consecutive transplants, failure of more than 6 high-quality embryos; 4. Abnormal vaginal bleeding of unknown cause; 5. Active pelvic inflammatory disease is known; 6. Malformations of reproductive organs known to be unsuitable for pregnancy; 7. Results of abnormal cervical cytology (TCT) within one year before screening; 8. Severe liver and kidney damage, heart disease, hypertension; 9. Previous or current history of thrombophlebitis or thromboembolic disease is known; 10. PLT < 100 x 10^9 / L, Hb < 100g / L; patients with hematological diseases, such as idiopathic thrombocytopenic purpura, etc; 11. Any known systemic disease with clinical significance (such as diabetes, tuberculosis, etc.); 12. Known history of recurrent abortion; 13. The chromosome karyotype of either husband or wife is abnormal; 14. Either of the husband and wife is suffering from a hereditary disease that is not suitable for childbearing as stipulated in the law on maternal and child health care; 15. Either of the husband and wife has been exposed to teratogenic radiation, poisons, and drugs; 16. Participated in clinical trials of other drugs or medical devices within 3 months before enrollment; 17. According to the investigator's judgment, there are any physical conditions / combined surgery/medication / other clinically significant abnormal laboratory tests that may affect the test results; 18. Those who are known to refuse or fail to comply with protocol requirements for any reason (including planned clinical visits and examinations).

Design outcomes

Primary

MeasureTime frame
Endometrial thickness;

Secondary

MeasureTime frame
Clinical pregnancy rate;Biochemical pregnancy rate;ongoing pregnancy rate;

Countries

China

Contacts

Public ContactXiaoyan Liang

The Sixth Affiliated Hospital of Sun Yat-Sen University

lxyzy@263.net+86 135 0001 5058

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026