hUC Mesenchymal Stem Cells (19#iSCLife®-UT) Therapy for Patients With Thin Endometrial Infertility
Primary Purpose
Infertility, Female
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
human umbilical cord mesenchymal stem cell complex collagen
intrauterine injection
Sponsored by
About this trial
This is an interventional treatment trial for Infertility, Female focused on measuring Thin Endometrial Infertility, hUCMSCs
Eligibility Criteria
Inclusion Criteria:
- Patients aged 20 to 39 years with primary or secondary infertility who have received ivf embryo transfer treatment and have been frozen at least 4 good quality embryos (good quality embryos defined as 7-9C / ⅱ 0 or 4BC or more blastocysts and ≥2 grade ⅰ embryos or 4BC or more blastocysts)
- Once above 2 times under hysteroscopy surgery adhesions, uterine cavity form has returned to normal, with normal menstrual cycle or at least a cycle high-dose estrogen replacement therapy for more than 12 days (> 4 mg/day, maximum dose of more than 8 mg/day), after treatment the biggest endometrial thickness of 7 mm or less or upper middle period of endometrial thickness of 7 mm or less on average; Or received assisted reproductive therapy, after at least 4mg/ day of estrogen, colony stimulating factor, aspirin, sildenafil and other drugs, unknown maximum endometrial thickness ≤7mm or average endometrial thickness ≤7mm in middle and upper segment; The maximum endometrial thickness in luteal phase was less than 6mm
- 18kg/m2< body mass index (BMI) <24 kg/m2
- Voluntarily participate and sign the informed consent
- Negative coV-19 nucleic acid test
Exclusion Criteria:
- Uncured sexually transmitted diseases
- Participate in other clinical investigators within 3 months
- Serum pregnancy tested positive
- Coagulopathy or other diseases of the blood system
- Severe heart disease, unstable angina attack, cardiac insufficiency of grade III or above, acute myocardial infarction and/or old myocardial infarction, hypertension was diagnosed according to the guidelines for prevention and treatment of hypertension in China (2010 edition)
- Patients with active genital tuberculosis
- Patients with immune system disorders
- Diseases related to pregnancy outcome (any) : Untreated hydrosalpinx, untreated uterine polyp, untreated uterine infection, phase III ~ Ⅳ endometriosis and adenomyosis of the uterus, ovarian cyst > 4 cm, uterine fibroids > 2 cm in diameter, multiple muscle intramural myoma, and submucosal fibroids, cesarean section incision site benign tumor prognosis, basin celiac > 4 cm, pituitary tumors and malignant tissues and organs tumors
- Abnormal uterine bleeding
- Severe liver and kidney function injury, namely, blood alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were 2.5 times higher than the upper limit of normal value, and blood creatinine (Cr) and urea nitrogen (BUN) were 2 times higher than the upper limit of normal value
- The researcher considers that she is not suitable for this study
Sites / Locations
- Xiangya Hospital Central South UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
stem cell and collagen transplantation group
control group
Arm Description
Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-UT)
collagen transplantation
Outcomes
Primary Outcome Measures
Pregnancy outcome
Pregnancy status is tracked for pregnancy rate, clinical pregnancy rate, ongoing pregnancy rate, miscarriage rate and live birth rate.
Secondary Outcome Measures
Intrauterine adhesion patients efficacy evaluation
Evaluated by Ultrasound B. The endometrium thickness increased ≥ 2mm and "B" or "A" endometrium appeared in the endometrium proliferation stage.
Irregular menstruation patients efficacy evaluation
Evaluated by Menstrual Blood Volume Scale. The menstrual cycle returned to normal and menstrual volume improved.
Poor endometrial receptivity patients efficacy evaluation
The criterion is clinical pregnancy and supplemented with ERT detection.
Full Information
NCT ID
NCT05495711
First Posted
July 20, 2022
Last Updated
April 11, 2023
Sponsor
Sclnow Biotechnology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05495711
Brief Title
hUC Mesenchymal Stem Cells (19#iSCLife®-UT) Therapy for Patients With Thin Endometrial Infertility
Official Title
A Clinical Research on Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-UT) Therapy for Patients With Thin Endometrial Infertility
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sclnow Biotechnology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To explore the therapeutic effect and safety of human umbilical cord mesenchymal stem cells on thin endometrial infertility and to explore whether human umbilical cord mesenchymal stem cells using collagen as the carrier can promote endometrial growth, reduce the recurrence rate of intrauterine adhesion, increase the clinical pregnancy rate, improve the pregnancy outcome, and study its safety.
Detailed Description
This is a random, open label, and self-control experiment. 24 patients are selected and sign consent forms, then divided into two groups. Doctors collect the basic information of patient (including age, BMI, mental condition, vital sign, history of disease, pharmaco-history, and so on.), evaluate the symptom of thin endometrial infertility (menstrual conditions, uterine cavity form, pregnancies).
All patients receive laboratory and image examination as baseline. Then, cell treatment will be given based on the clinical protocol. Doctors have follow-up visit on 1, 3, 6, 12 month after treatment, and do efficacy evaluation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female
Keywords
Thin Endometrial Infertility, hUCMSCs
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
randomize double-blind
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
stem cell and collagen transplantation group
Arm Type
Experimental
Arm Description
Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-UT)
Arm Title
control group
Arm Type
Active Comparator
Arm Description
collagen transplantation
Intervention Type
Biological
Intervention Name(s)
human umbilical cord mesenchymal stem cell complex collagen
Intervention Description
1 * 10^7 cells (2ml)
Intervention Type
Procedure
Intervention Name(s)
intrauterine injection
Intervention Description
intrauterine injection with human umbilical cord mesenchymal stem cell (19#iSCLife®-UT); total 1 time
Primary Outcome Measure Information:
Title
Pregnancy outcome
Description
Pregnancy status is tracked for pregnancy rate, clinical pregnancy rate, ongoing pregnancy rate, miscarriage rate and live birth rate.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Intrauterine adhesion patients efficacy evaluation
Description
Evaluated by Ultrasound B. The endometrium thickness increased ≥ 2mm and "B" or "A" endometrium appeared in the endometrium proliferation stage.
Time Frame
12 months
Title
Irregular menstruation patients efficacy evaluation
Description
Evaluated by Menstrual Blood Volume Scale. The menstrual cycle returned to normal and menstrual volume improved.
Time Frame
12 months
Title
Poor endometrial receptivity patients efficacy evaluation
Description
The criterion is clinical pregnancy and supplemented with ERT detection.
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 20 to 39 years with primary or secondary infertility who have received ivf embryo transfer treatment and have been frozen at least 4 good quality embryos (good quality embryos defined as 7-9C / ⅱ 0 or 4BC or more blastocysts and ≥2 grade ⅰ embryos or 4BC or more blastocysts)
Once above 2 times under hysteroscopy surgery adhesions, uterine cavity form has returned to normal, with normal menstrual cycle or at least a cycle high-dose estrogen replacement therapy for more than 12 days (> 4 mg/day, maximum dose of more than 8 mg/day), after treatment the biggest endometrial thickness of 7 mm or less or upper middle period of endometrial thickness of 7 mm or less on average; Or received assisted reproductive therapy, after at least 4mg/ day of estrogen, colony stimulating factor, aspirin, sildenafil and other drugs, unknown maximum endometrial thickness ≤7mm or average endometrial thickness ≤7mm in middle and upper segment; The maximum endometrial thickness in luteal phase was less than 6mm
18kg/m2< body mass index (BMI) <24 kg/m2
Voluntarily participate and sign the informed consent
Negative coV-19 nucleic acid test
Exclusion Criteria:
Uncured sexually transmitted diseases
Participate in other clinical investigators within 3 months
Serum pregnancy tested positive
Coagulopathy or other diseases of the blood system
Severe heart disease, unstable angina attack, cardiac insufficiency of grade III or above, acute myocardial infarction and/or old myocardial infarction, hypertension was diagnosed according to the guidelines for prevention and treatment of hypertension in China (2010 edition)
Patients with active genital tuberculosis
Patients with immune system disorders
Diseases related to pregnancy outcome (any) : Untreated hydrosalpinx, untreated uterine polyp, untreated uterine infection, phase III ~ Ⅳ endometriosis and adenomyosis of the uterus, ovarian cyst > 4 cm, uterine fibroids > 2 cm in diameter, multiple muscle intramural myoma, and submucosal fibroids, cesarean section incision site benign tumor prognosis, basin celiac > 4 cm, pituitary tumors and malignant tissues and organs tumors
Abnormal uterine bleeding
Severe liver and kidney function injury, namely, blood alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were 2.5 times higher than the upper limit of normal value, and blood creatinine (Cr) and urea nitrogen (BUN) were 2 times higher than the upper limit of normal value
The researcher considers that she is not suitable for this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanping Li
Phone
13607317798
Email
michaelliang@sclnow.com
Facility Information:
Facility Name
Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanping Li
Phone
13607317798
Email
michaelliang@sclnow.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
hUC Mesenchymal Stem Cells (19#iSCLife®-UT) Therapy for Patients With Thin Endometrial Infertility
We'll reach out to this number within 24 hrs