Thin EndometriumNCT03724617
Clinical Study of Umbilical Cord Mesenchymal Stem Cells Combined With Collagen Scaffold in the Treatment of Thin Endometrium
A study testing umbilical cord mesenchymal stem cells combined with collagen scaffold in people with Thin Endometrium and Intrauterine Adhesion, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
This is a non-blind self-control trial. We mainly compare the changes of endometrial thickness，changes in menstrual flow, and improvement in pregnancy before and after stem cell treatment in patients with thin endometrium. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Thin Endometrium, Intrauterine Adhesion
- What is being tested?
- umbilical cord mesenchymal stem cells combined with collagen scaffold
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 29 Oct 2018to 31 Dec 2020
- Phase
- Interventional
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- According to the GCP regulations, obtain the informed consent of the subject, volunteer for the test, and have signed the informed consent form.
- Women aged 20-40 years with fertility requirements
- Infertility patients who are treated in this hospital
- After more than 2 times of hysteroscopic adhesion separation surgery, the uterine cavity morphology has basically returned to normal. The patient has a normal menstrual cycle or an estrogenic dose of 6 mg per day, and the highest thickness of the endometrium is 5.5 mm in 6 cycles by ultrasound.
- or receive adjuvant reproductive treatment, the endometrial thickness is less than 5.5mm for unknown reasons, the treatment of estrogen, colony stimulating factor, aspirin, sildenafil and other drugs up to 8mg / day is invalid.
- HBVAg negative, HCV negative, HIV negative, syphilis negative
- Normal bone marrow morphology, normal blood routine
- Previously failed to receive relevant stem cell therapy
Who cannot join
- Those who cannot accept the treatment observation process required by the test
- There are contraindications for hysteroscopic surgery;
- congenital uterine malformation; severe adenomyosis; uterine fibroids that may affect embryo implantation; the investigators judged that there are other uterine factors that are not suitable for embryo implantation
- Patients with chromosomal abnormalities
- contraindications to estrogen therapy; systemic diseases such as thrombosis, cardiopulmonary disease, hematopoietic diseases, malignant tumors, etc.
- Patients without fertility requirements
Trial locations and contacts
1 site in 1 country.
China1 site
Sir Run Run Shaw hopital,School of medicine,Zhejiang University
Hangzhou
About this study
Official title: Clinical Study of Stem Cells in the Treatment of Thin Endometrium
This is a non-blind self-control trial. We mainly compare the changes of endometrial thickness，changes in menstrual flow, and improvement in pregnancy before and after stem cell treatment in patients with thin endometrium.
Read the detailed description
According to the medical history and the results of the examination, the selected cases were screened and the informed consent was signed. After hysteroscopy, the collagen/umbilical cord mesenchymal stem cell was spread on a foley catheter, and placed in the uterine cavity, and 5 ml of saline was filled into the balloon. B-ultrasound confirmed that the stent was attached to the uterine wall. The balloon was removed in situ after 1 week. We mainly compare the endometrial thickness before and 6 months after surgery.
- Conditions
- Thin Endometrium, Intrauterine Adhesion
- Being tested
- umbilical cord mesenchymal stem cells combined with collagen scaffold
- Keywords
- thin endometrium, Intrauterine Adhesion, stem cell, Collagen scaffold
- Medical subject headings
- Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
umbilical cord mesenchymal stem cells combined with collagen scaffoldDrug
3-7 days after the end of menstruation, we underwent hysteroscopic exploration and separation if there was intrauterine adhesions. Intraoperative endometrial biopsy, recording biopsy location, endometrial specimens sent to HE examination and immunohistochemistry (vwf detection of microvessel density). The umbilical cord mesenchymal stem cell combined with collagen scaffold was spread on the balloon scaffold and placed in the uterine cavity. 5 ml of saline was filled into the balloon, and B-ultrasound confirmed that the scaffold was attached to the uterine wall. The patient was hospitalized for 2 hours and the patient's vital signs were recorded.
| Study group | Role | What they receive |
|---|---|---|
| stem cell therapy | Experimental | Not described Receives: Drug: umbilical cord mesenchymal stem cells combined with collagen scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of endometrial thickness
B-ultrasound measures and compares the endometrial thickness of the luteal phase before and after administration.
Measured: Change from Baseline endometrial thickness at 6 months
Secondary outcomes (3)
pregnancy rate
pregnancy rate = (pregnancy / observations) × 100%
Measured: pregnancy rate at 1 year
live birth rate
live birth rate = (live births / observations) × 100%
Measured: live birth rate at 1 year
abortion rate
abortion rate = (number of abortions / observations) × 100%
Measured: abortion rate at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start29 Oct 2018
- Primary completion30 Jun 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thin EndometriumStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaona Lin, Sir Run Run Shaw Hospital
- Investigators
- Xiaona Lin, Study chair, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724617
- Sponsor's protocol ID
- SRRSHRMC20180924
- Status last verified
- Oct 2018
- First submitted
- 26 Oct 2018
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhang Y, Shi L, Lin X, Zhou F, Xin L, Xu W, Yu H, Li J, Pan M, Pan Y, Dai Y, Zhang Y, Shen J, Zhao L, Lu M, Zhang S. Unresponsive thin endometrium caused by Asherman syndrome treated with umbilical cord mesenchymal stem cells on collagen scaffolds: a pilot study. Stem Cell Res Ther. 2021 Jul 22;12(1):420. doi: 10.1186/s13287-021-02499-z.
PubMed 34294152
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Stem Cells in the Treatment of Thin Endometrium
- ClinicalTrials.gov ID
- NCT03724617
- Acronym / sponsor ID
- SRRSHRMC20180924
- Conditions
- Thin Endometrium, Intrauterine Adhesion
- Keywords
- thin endometrium, Intrauterine Adhesion, stem cell, Collagen scaffold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 30 Oct 2018 (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.
This is a non-blind self-control trial. We mainly compare the changes of endometrial thickness，changes in menstrual flow, and improvement in pregnancy before and after stem cell treatment in patients with thin endometrium.
Detailed description
According to the medical history and the results of the examination, the selected cases were screened and the informed consent was signed. After hysteroscopy, the collagen/umbilical cord mesenchymal stem cell was spread on a foley catheter, and placed in the uterine cavity, and 5 ml of saline was filled into the balloon. B-ultrasound confirmed that the stent was attached to the uterine wall. The balloon was removed in situ after 1 week. We mainly compare the endometrial thickness before and 6 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stem cell therapy | Experimental | Drug: umbilical cord mesenchymal stem cells combined with collagen scaffold |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- According to the GCP regulations, obtain the informed consent of the subject, volunteer for the test, and have signed the informed consent form.
- Women aged 20-40 years with fertility requirements
- Infertility patients who are treated in this hospital
- After more than 2 times of hysteroscopic adhesion separation surgery, the uterine cavity morphology has basically returned to normal. The patient has a normal menstrual cycle or an estrogenic dose of 6 mg per day, and the highest thickness of the endometrium is 5.5 mm in 6 cycles by ultrasound.
- or receive adjuvant reproductive treatment, the endometrial thickness is less than 5.5mm for unknown reasons, the treatment of estrogen, colony stimulating factor, aspirin, sildenafil and other drugs up to 8mg / day is invalid.
Key exclusion criteria (6 listed)
- Those who cannot accept the treatment observation process required by the test
- There are contraindications for hysteroscopic surgery;
- congenital uterine malformation; severe adenomyosis; uterine fibroids that may affect embryo implantation; the investigators judged that there are other uterine factors that are not suitable for embryo implantation
- Patients with chromosomal abnormalities
- contraindications to estrogen therapy; systemic diseases such as thrombosis, cardiopulmonary disease, hematopoietic diseases, malignant tumors, etc.
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 |
|---|---|---|
| umbilical cord mesenchymal stem cells combined with collagen scaffold3-7 days after the end of menstruation, we underwent hysteroscopic exploration and separation if there was intrauterine adhesions. Intraoperative endometrial biopsy, recording biopsy location, endometrial specimens sent to HE examination and immunohistochemistry (vwf detection of microvessel density). The umbilical cord mesenchymal stem cell combined with collagen scaffold was spread on the balloon scaffold and placed in the uterine cavity. 5 ml of saline was filled into the balloon, and B-ultrasound confirmed that the scaffold was attached to the uterine wall. The patient was hospitalized for 2 hours and the patient's vital signs were recorded. | Drug | stem cell therapy |
Primary outcome
the change of endometrial thickness
Time frame: Change from Baseline endometrial thickness at 6 months
B-ultrasound measures and compares the endometrial thickness of the luteal phase before and after administration.
3 secondary outcomes
pregnancy rate
Time frame: pregnancy rate at 1 year
live birth rate
Time frame: live birth rate at 1 year
abortion rate
Time frame: abortion rate at 1 year
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 13 Apr 2021.
- Derived from this study: PubMed 34294152Zhang Y, Shi L, Lin X, Zhou F, Xin L, Xu W, Yu H, Li J, Pan M, Pan Y, Dai Y, Zhang Y, Shen J, Zhao L, Lu M, Zhang S. Unresponsive thin endometrium caused by Asherman syndrome treated with umbilical cord mesenchymal stem cells on collagen scaffolds: a pilot study. Stem Cell Res Ther. 2021 Jul 22;12(1):420. doi: 10.1186/s13287-021-02499-z.
- Individual participant dataSharing planned: Undecided
Related trials for Thin Endometrium
Recruiting
CURENDO (Cord-blood Uterine Regeneration Endometrium): Platelet-rich Plasma Therapy Derived From Umbilical Cord Blood for the Treatment of Endometrial Pathologies (Asherman Syndrome / Endometrial Atrophy / Thin Endometrium)
Asherman Syndrome
Not yet recruitingPhase 3
Intrauterine G-CSF Infusion for Thin Endometrium
Thin Endometrium, Female Infertility
Not yet recruiting
Experimental Study on the Use of Intrauterine Infusion of Autologous Platelet-rich Plasma (PRGF-IUI) in Patients With Recurrent Implantation Failure and/or Refractory Thin Endometrium
Recurrent Implantation Failure, Endometrial Receptivity Disorders
Recruiting
A Randomized Controlled Study on the Effect of MRJPs on Improving Ovarian Function and Endometrial Receptivity
Diminished Ovarian Reserve (DOR), Thin Endometrium
RecruitingPhase 1
AD-SVF Therapy for Refractory Endometrial Infertility
Endometrium; Atrophy, Intrauterine Synechiae
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.
Xiaona Lin study chair
Sir Run Run Shaw Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing umbilical cord mesenchymal stem cells combined with collagen scaffold in people with Thin Endometrium and Intrauterine Adhesion, run by Sir Run Run Shaw Hospital 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 8 inclusion and 6 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 13 Apr 2021. 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.
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?
the change of endometrial thickness (time frame: Change from Baseline endometrial thickness at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03724617, which also lists 1 linked publication.
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 13 Apr 2021.