Infertility, FemalePhase 1NCT05495711
hUC Mesenchymal Stem Cells (19#iSCLife®-UT) Therapy for Patients With Thin Endometrial Infertility
A Phase 1 study testing human umbilical cord mesenchymal stem cell complex collagen and intrauterine injection in people with Infertility, Female, run by Sclnow Biotechnology Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- human umbilical cord mesenchymal stem cell complex collagen and intrauterine injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 1 Nov 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Research on Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-UT) Therapy for Patients With Thin Endometrial Infertility
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.
Read the 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.
- Conditions
- Infertility, Female
- Being tested
- human umbilical cord mesenchymal stem cell complex collagen, intrauterine injection
- Keywords
- Thin Endometrial Infertility, hUCMSCs
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human umbilical cord mesenchymal stem cell complex collagenBiological
1 * 10^7 cells (2ml)
intrauterine injectionProcedure or surgery
intrauterine injection with human umbilical cord mesenchymal stem cell (19#iSCLife®-UT); total 1 time
| Study group | Role | What they receive |
|---|---|---|
| stem cell and collagen transplantation group | Experimental | Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-UT) Receives: Biological: human umbilical cord mesenchymal stem cell complex collagen |
| control group | Active comparator | collagen transplantation Receives: Biological: human umbilical cord mesenchymal stem cell complex collagen; Procedure: intrauterine injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy outcome
Pregnancy status is tracked for pregnancy rate, clinical pregnancy rate, ongoing pregnancy rate, miscarriage rate and live birth rate.
Measured: 12 months
Secondary outcomes (3)
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.
Measured: 12 months
Irregular menstruation patients efficacy evaluation
Evaluated by Menstrual Blood Volume Scale. The menstrual cycle returned to normal and menstrual volume improved.
Measured: 12 months
Poor endometrial receptivity patients efficacy evaluation
The criterion is clinical pregnancy and supplemented with ERT detection.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start1 Aug 2022
- Primary completion1 Jun 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sclnow Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495711
- Sponsor's protocol ID
- SCLnow-XY-05
- Status last verified
- May 2025
- First submitted
- 20 Jul 2022
- Last updated
- 22 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Research on Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-UT) Therapy for Patients With Thin Endometrial Infertility
- ClinicalTrials.gov ID
- NCT05495711
- Acronym / sponsor ID
- SCLnow-XY-05
- Conditions
- Infertility, Female
- Keywords
- Thin Endometrial Infertility, hUCMSCs
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sclnow Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stem cell and collagen transplantation group | Experimental | Biological: human umbilical cord mesenchymal stem cell complex collagenHuman Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-UT) |
| control group | Active comparator | Biological: human umbilical cord mesenchymal stem cell complex collagen, Procedure: intrauterine injectioncollagen transplantation |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| human umbilical cord mesenchymal stem cell complex collagen1 * 10^7 cells (2ml) | Biological | control group, stem cell and collagen transplantation group |
| intrauterine injectionintrauterine injection with human umbilical cord mesenchymal stem cell (19#iSCLife®-UT); total 1 time | Procedure or surgery | control group |
Primary outcome
Pregnancy outcome
Time frame: 12 months
Pregnancy status is tracked for pregnancy rate, clinical pregnancy rate, ongoing pregnancy rate, miscarriage rate and live birth rate.
3 secondary outcomes
Intrauterine adhesion patients efficacy evaluation
Time frame: 12 months
Irregular menstruation patients efficacy evaluation
Time frame: 12 months
Poor endometrial receptivity patients efficacy evaluation
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: No
Related trials for Infertility, Female
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingPhase 2
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Functional Hypothalamic Amenorrhea, FHA
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing human umbilical cord mesenchymal stem cell complex collagen and intrauterine injection in people with Infertility, Female, run by Sclnow Biotechnology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy outcome (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.