The Efficacy and Safety of Collagen Scaffold Loaded With Umbilical Cord Derived Mesenchymal Stem Cells in Infertile Women With Thin Endometrium or Endometrial Scarring

Infertility, Female Clinical Trial

Official title:

The Efficacy and Safety of Collagen Scaffold Loaded With Umbilical Cord Derived Mesenchymal Stem Cells in Infertile Women With Thin Endometrium or Endometrial Scarring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03592849
• Other study ID #: SC201700101
• Status: Completed
• Phase: N/A
• Start date: September 10, 2018
• Est. completion date: August 31, 2022

Study information

• Verified date: September 2022
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the safety and effectiveness of the collagen scaffold loaded with umbilical cord derived mesenchymal stem cells (UC-MSCs) in infetile women with thin endometrium or endometrial scarring.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 31, 2022
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 42 Years

Eligibility

Inclusion Criteria:

1. Infertile patients with clear fertility desires

2. Diagnosed with thin endometrium or endometrial scarring for whom drugs and surgical interventions were ineffective

3. 20-42 years old

4. Normal ovarian function or with frozen embryos

5. Willing to actively cooperate with postoperative follow-up

Exclusion Criteria:

1. With abnormal chromosome karyotype

2. With other uterine diseases including large intramural myomas, severe endometriosis, severe adenomyosis, severe congenital uterine malformations, endometrial tuberculosis, vaginitis and endometritis

3. Systemic diseases: hypertension, diabetes, and so on

4. Contraindications to pregnancy

5. Contraindications to hormone replacement therapy

6. Medical history of pelvic tumors or receiving pelvic radiotherapy

7. Involved in other clinical studies

8. Unable to adhere to the follow-up

Related Conditions & MeSH terms

• Endometrium
• Infertility
• Infertility, Female

Intervention

Procedure:
• UC-MSCs therapy
After history taking, physical examination, ultrasound examination and hysteroscopy examination,infertile women diagnosed with thin endometrium or endometrial scarring will be included in the clinical trial. A collagen scaffold loaded with UC-MSCs will be transplanted into the uterine cavity during hysteroscopy, and participants will receive hormone replacement therapy before and after the treatment. Postoperative observations including ultrasound examination once a month for 3 times and hysteroscopy in the third month after first UC-MSCs therapy. Those whose endometrium is suitable for pregnancy will be recommended attempting conception actively. The next round of cell therapy will be conducted 3 cycles after the first month if the endometrial growth is unsatisfactory.

Locations

Country	Name	City	State
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	menstrual blood volume	the change of menstrual blood volume after surgery compared with pre-operation	baseline and 6 month postoperation
Other	adverse event rate	the occurrence of infections?allergies?abdominal pain postoperation	30 months
Primary	endometrial thickness	endometrium thickness evaluated by transvaginal sonography during late proliferating phase	12 months
Secondary	ongoing pregnancy rate	the presence of a living intrauterine fetus on TVU at the 12th week of gestation	24 months
Secondary	live birth rate	a live born baby =28 weeks of gestation	24 months
Secondary	endometrial blood flow	uterine blood flow evaluated by transvaginal sonography	6 months