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

• ClinicalTrials.gov Identifier: NCT03592849
• Recruitment Status: Enrolling by invitation
• First Posted: July 19, 2018
• Last Update Posted: January 10, 2020
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Information provided by (Responsible Party): Yali Hu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Infertility, Female; Endometrium	Procedure: UC-MSCs therapy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: September 10, 2018
• Estimated Primary Completion Date: December 2020
• Estimated Study Completion Date: December 2021

Arms and Interventions

Arm

Intervention/treatment

Experimental: UC-MSCs therapy; transplant collagen scaffold loaded with UC-MSCs to treat infertility caused by thin endometrium or endometrial scarring

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.; Other Name: collagen scaffold

Outcome Measures

Primary Outcome Measures :

1. endometrial thickness [ Time Frame: 12 months ]
   endometrium thickness evaluated by transvaginal sonography during late proliferating phase

Secondary Outcome Measures :

1. ongoing pregnancy rate [ Time Frame: 24 months ]
   the presence of a living intrauterine fetus on TVU at the 12th week of gestation
2. live birth rate [ Time Frame: 24 months ]
   a live born baby ≥28 weeks of gestation
3. endometrial blood flow [ Time Frame: 6 months ]
   uterine blood flow evaluated by transvaginal sonography

Other Outcome Measures:

1. menstrual blood volume [ Time Frame: baseline and 6 month postoperation ]
   the change of menstrual blood volume after surgery compared with pre-operation
2. adverse event rate [ Time Frame: 30 months ]
   the occurrence of infections、allergies、abdominal pain postoperation

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 42 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

China, Jiangsu

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China, 210008

Sponsors and Collaborators

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Investigators

• Principal Investigator: Yali Hu, MD,PhD; The Affiliated Drum Tower Hospital of Nanjing University Medical School

More Information

• Responsible Party: Yali Hu, Professor，Chief Physician of Obstetrics and Gynecology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• ClinicalTrials.gov Identifier: NCT03592849
• Other Study ID Numbers: SC201700101
• First Posted: July 19, 2018
• Last Update Posted: January 10, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Within six months after the trial complete

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yali Hu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School:

thin endometrium; infertility

Additional relevant MeSH terms:

Infertility; Infertility, Female