InfertilityNCT02313415
Treatment of Infertility by Collagen Scaffold Loaded With Umbilical Cord Derived Mesenchyma Stem Cells
A study testing UC-MSCs therapy in people with Infertility and Intrauterine Adhesions, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
Study of the treatment of infertility caused by recurrent intrauterine adhesions (IUA) by collagen scaffold loaded with umbilical cord derived mesenchymal stem cells (UC-MSCs) to provide clinical evidence of safety and effectiveness for the treatment of uterine infertility. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Infertility, Intrauterine Adhesions
- What is being tested?
- UC-MSCs therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 28 Nov 2014to 31 Aug 2017
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Secondary infertility or failure of embryo transfer caused by recurrent intrauterine adhesions who desired to be pregnant
- Hysteroscopy examination confirmed intrauterine adhesions
- Sign a consent form
- Follow the test plan and follow-up process
Who cannot join
- have hysteroscopic contraindications
- Chromosome karyotype abnormalities
- Congenital uterine malformations
- Severe adenomyosis
- Contraindications to estradiol treatment
- Medical history of pelvic tumors or receiving pelvic radiotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study of the Treatment of Infertility Caused by Recurrent Intrauterine Adhesions by Collagen Scaffold Loaded With Umbilical Cord -Derived Mesenchymal Stem Cells (UC-MSCs)
Study of the treatment of infertility caused by recurrent intrauterine adhesions (IUA) by collagen scaffold loaded with umbilical cord derived mesenchymal stem cells (UC-MSCs) to provide clinical evidence of safety and effectiveness for the treatment of uterine infertility.
Read the detailed description
Infertility is defined as a women fails to become pregnant after having a normal sex life for two years without contraception. There is limited treatment to the infertility caused by severe IUA especially recurrent IUA after adhesiolysis which hinders embryos implantation. The existing drugs, physical or surgical treatments had no significant effects to severe recurrent intrauterine adhesions. Collagen is the main component of the extracellular matrix with good biocompatibility, UC-MSCs have been used in the clinical treatment of diseases, and achieved good results. In this study, collagen scaffold and umbilical cord blood-derived mesenchymal stem cells are combined, and they showed good biological safety.
- Conditions
- Infertility, Intrauterine Adhesions
- Being tested
- UC-MSCs therapy
- Medical subject headings
- Infertility, Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UC-MSCs therapyProcedure or surgery
Before considering whether patients meet the inclusion criteria, they are diagnosed as intrauterine adhesions with at least one unsuccessful hysteroscopic surgery. And after that there will be history taking, physical examination, ultrasound examination and hysteroscopy examination. If they agree to participate, they will receive separation of adhesions by hysteroscopy surgery and endometrial biopsies, then a collagen scaffold loaded with UC-MSCs will be transplanted into the uterine cavity. The procedure was performed after taking 6 mg/day × 10 days Progynova, continuous administration of the same dosage Progynova for 30 days and 60mg of progesterone were injected on the 30th day post-operation. Postoperative observation including ultrasound examination once a month for 3 times and hysteroscopy after 3 months. The doctor will select an appropriate time for pregnancy and follow-up including requiring patients to do some unscheduled visits.
| Study group | Role | What they receive |
|---|---|---|
| UC-MSCs therapy | Experimental | transplant collagen scaffold loaded with UC-MSCs to treat infertility caused by recurrent intrauterine adhesions Receives: Procedure: UC-MSCs therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
live birth rate
A baby born alive after 20 weeks gestation was classified as a live birth.
Measured: 30 months
Secondary outcomes (3)
Reduction of intrauterine adhesion
Hysteroscopic inspection to verify degree of adhesion
Measured: 3 months post-surgery
The change of endometrial thickness
Measure the endometrial thickness during late proliferating phase by ultrasound
Measured: up to 3 months
ongoing pregnant rate
The presence of at least one fetus with heart pulsation on ultrasound beyond 8 weeks
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2014 (estimated)
- Study start28 Nov 2014
- Primary completion28 Jan 2015
- Study completion31 Aug 2017
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 InfertilityStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- Model description
- treatment of infertility caused by recurrent intrauterine adhesions by collagen scaffold loaded with UC-MSCs
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Sciences, Institute of Zoology, Chinese Academy of Sciences
- Responsible party
- Principal investigator, Yali Hu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Yali HU, MD,PhD, Principal investigator, Vice-president of the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313415
- Sponsor's protocol ID
- 20141206
- Status last verified
- Oct 2017
- First submitted
- 7 Dec 2014
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Cao Y, Sun H, Zhu H, Zhu X, Tang X, Yan G, Wang J, Bai D, Wang J, Wang L, Zhou Q, Wang H, Dai C, Ding L, Xu B, Zhou Y, Hao J, Dai J, Hu Y. Allogeneic cell therapy using umbilical cord MSCs on collagen scaffolds for patients with recurrent uterine adhesion: a phase I clinical trial. Stem Cell Res Ther. 2018 Jul 11;9(1):192. doi: 10.1186/s13287-018-0904-3.
PubMed 29996892
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Treatment of Infertility Caused by Recurrent Intrauterine Adhesions by Collagen Scaffold Loaded With Umbilical Cord -Derived Mesenchymal Stem Cells (UC-MSCs)
- ClinicalTrials.gov ID
- NCT02313415
- Acronym / sponsor ID
- 20141206
- Conditions
- Infertility, Intrauterine Adhesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Collaborators
- Chinese Academy of Sciences, Institute of Zoology, Chinese Academy of Sciences
- Study start
- 28 Nov 2014 (actual)
- Primary completion
- 28 Jan 2015 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 10 Dec 2014 (estimated)
- 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.
Study of the treatment of infertility caused by recurrent intrauterine adhesions (IUA) by collagen scaffold loaded with umbilical cord derived mesenchymal stem cells (UC-MSCs) to provide clinical evidence of safety and effectiveness for the treatment of uterine infertility.
Detailed description
Infertility is defined as a women fails to become pregnant after having a normal sex life for two years without contraception. There is limited treatment to the infertility caused by severe IUA especially recurrent IUA after adhesiolysis which hinders embryos implantation. The existing drugs, physical or surgical treatments had no significant effects to severe recurrent intrauterine adhesions. Collagen is the main component of the extracellular matrix with good biocompatibility, UC-MSCs have been used in the clinical treatment of diseases, and achieved good results. In this study, collagen scaffold and umbilical cord blood-derived mesenchymal stem cells are combined, and they showed good biological safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- treatment of infertility caused by recurrent intrauterine adhesions by collagen scaffold loaded with UC-MSCs
| Arm | Type | Receives |
|---|---|---|
| UC-MSCs therapy | Experimental | Procedure: UC-MSCs therapytransplant collagen scaffold loaded with UC-MSCs to treat infertility caused by recurrent intrauterine adhesions |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Secondary infertility or failure of embryo transfer caused by recurrent intrauterine adhesions who desired to be pregnant
- Hysteroscopy examination confirmed intrauterine adhesions
- Sign a consent form
- Follow the test plan and follow-up process
Key exclusion criteria (6 listed)
- have hysteroscopic contraindications
- Chromosome karyotype abnormalities
- Congenital uterine malformations
- Severe adenomyosis
- Contraindications to estradiol treatment
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 |
|---|---|---|
| UC-MSCs therapyBefore considering whether patients meet the inclusion criteria, they are diagnosed as intrauterine adhesions with at least one unsuccessful hysteroscopic surgery. And after that there will be history taking, physical examination, ultrasound examination and hysteroscopy examination. If they agree to participate, they will receive separation of adhesions by hysteroscopy surgery and endometrial biopsies, then a collagen scaffold loaded with UC-MSCs will be transplanted into the uterine cavity. The procedure was performed after taking 6 mg/day × 10 days Progynova, continuous administration of the same dosage Progynova for 30 days and 60mg of progesterone were injected on the 30th day post-operation. Postoperative observation including ultrasound examination once a month for 3 times and hysteroscopy after 3 months. The doctor will select an appropriate time for pregnancy and follow-up including requiring patients to do some unscheduled visits. | Procedure or surgery | UC-MSCs therapy |
Primary outcome
live birth rate
Time frame: 30 months
A baby born alive after 20 weeks gestation was classified as a live birth.
3 secondary outcomes
Reduction of intrauterine adhesion
Time frame: 3 months post-surgery
The change of endometrial thickness
Time frame: up to 3 months
ongoing pregnant rate
Time frame: 30 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 24 Oct 2017.
- Derived from this study: PubMed 29996892Cao Y, Sun H, Zhu H, Zhu X, Tang X, Yan G, Wang J, Bai D, Wang J, Wang L, Zhou Q, Wang H, Dai C, Ding L, Xu B, Zhou Y, Hao J, Dai J, Hu Y. Allogeneic cell therapy using umbilical cord MSCs on collagen scaffolds for patients with recurrent uterine adhesion: a phase I clinical trial. Stem Cell Res Ther. 2018 Jul 11;9(1):192. doi: 10.1186/s13287-018-0904-3.
- Individual participant dataSharing planned: No
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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.
Yali HU, MD,PhD principal investigator
Vice-president of the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UC-MSCs therapy in people with Infertility and Intrauterine Adhesions, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 4 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 24 Oct 2017. 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?
live birth rate (time frame: 30 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 NCT02313415, 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 24 Oct 2017.