Uterine ScarPhase 1NCT03181087
Safety of Umbilical Cord Mesenchymal Stem Cell Local Intramuscular Injection for Treatment of Uterine Scars
A Phase 1 study testing Umbilical cord MSCs in people with Uterine Scar, run by Maternal and Child Health Hospital of Foshan at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety of umbilical cord mesenchymal stem cell local intramuscular injection for treatment of uterine scars by a prospective, single-center, open, and single-arm clinical trial. Read more about this study
- Who is it for?
- Ages 21 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Scar
- What is being tested?
- Umbilical cord MSCs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 11 Dec 2021to 30 May 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 21 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primiparous women receiving cesarean delivery
- Ages between 21-35 years
- Gestation ages ≥ 37 weeks and < 42 weeks
- Willing to comply with study dosing and completed the entire course of the study
- Willing to give and sign an informed consent form and a photographic release form
Who cannot join
- Fibroids
- Placenta previa
- Placenta abruption
- Multiple gestation
- Antepartum hemorrhage
- Preeclampsia/Eclampsia
Show all 9Show fewer
- Hepatic or renal dysfunction
- Any systemic uncontrolled disease
- Inability to provide consent
Trial locations and contacts
1 site in 1 country.
China1 site
Maternal and Child Health Hospital of Foshan
Foshan, Guangdong, 528000
About this study
Official title: A Phase I, Single-arm, Open Study of the Safety of Umbilical Cord Mesenchymal Stem Cell Local Intramuscular Injection for Treatment of Uterine Scars
The purpose of this study is to evaluate the safety of umbilical cord mesenchymal stem cell local intramuscular injection for treatment of uterine scars by a prospective, single-center, open, and single-arm clinical trial.
- Conditions
- Uterine Scar
- Being tested
- Umbilical cord MSCs
- Keywords
- Mesenchymal Stem Cells, Cesarean Section, Uterine Scar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical cord MSCsOther
Participants will receive direct local intramuscular injection of 1*10^7 MSCs (in 1ml of 0.9% saline) in the uterine incision.
| Study group | Role | What they receive |
|---|---|---|
| Umbilical cord MSCs Group | Experimental | 1*10^7 Umbilical cord Mesenchymal Stem Cells (MSCs) Receives: Other: Umbilical cord MSCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety evaluation through vital signs, the results of clinical lab tests and adverse events
Safety evaluation through vital signs, the results of clinical lab tests and adverse events.
Measured: 6 months post treatment
Secondary outcomes (7)
Number of participants with uterine niche
The niche is defined as a triangular anechoic area at the presumed site of incision in the uterus by transvaginal utrasonography.
Measured: 6 months post treatment
Change of uterine scar thickness
The scar thickness be measured using a transvaginal utrasonography
Measured: 6 weeks, 3 and 6 months post treatment
Change of uterine scar area
The scar area will be measured using a transvaginal utrasonography
Measured: 6 weeks, 3 and 6 months post treatment
Number of participants with endometritis
Endometritis is defined as the presence of at least two of the following signs with no other recognized cause: fever (temperature of at least 38℃), abdominal pain, uterine tenderness, or purulent drainage from the uterus.
Measured: 6 months post treatment
Number of participants with wound infection
Wound infection is defined as the presence of either superficial or deep incisional surgical-site infection characterized by cellulitis or erythema and induration around the incision or purulent discharge from the incision site with or without fever and included necrotizing fasciitis.
Measured: 6 months post treatment
Immunoglobulin concentrations in breast milk and serum
Breast milk and serum immunoglobulin (IgG, IgA, IgM) and the complement (C3, C4) are detected by transmission immune turbidity method using automatic biochemical analyzer.
Measured: 6 weeks, 3 and 6 months post treatment
Adverse events occurrence
Adverse events will be evaluated since the baseline visit until 6 months after the end of the treatment.
Measured: 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start11 Dec 2021 (estimated)
- Primary completion31 Oct 2022 (estimated)
- Study completion30 May 2023 (estimated)
Why it stopped: The pandemic resulted in no enrollments.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine ScarStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maternal and Child Health Hospital of Foshan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhengping Liu, MD, Maternal and Child Health Hospital of Foshan
- Investigators
- Zhengping Liu, MD, Principal investigator, Maternal and Child Health Hospital of Foshan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181087
- Sponsor's protocol ID
- MCHHFoshan-1701
- Status last verified
- Dec 2022
- First submitted
- 7 Jun 2017
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-arm, Open Study of the Safety of Umbilical Cord Mesenchymal Stem Cell Local Intramuscular Injection for Treatment of Uterine Scars
- ClinicalTrials.gov ID
- NCT03181087
- Acronym / sponsor ID
- MCHHFoshan-1701
- Conditions
- Uterine Scar
- Keywords
- Mesenchymal Stem Cells, Cesarean Section, Uterine Scar
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The pandemic resulted in no enrollments.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Maternal and Child Health Hospital of FoshanUniversity, hospital or other
- Study start
- 11 Dec 2021 (estimated)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 8 Jun 2017 (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.
The purpose of this study is to evaluate the safety of umbilical cord mesenchymal stem cell local intramuscular injection for treatment of uterine scars by a prospective, single-center, open, and single-arm clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Umbilical cord MSCs Group | Experimental | Other: Umbilical cord MSCs1*10^7 Umbilical cord Mesenchymal Stem Cells (MSCs) |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Primiparous women receiving cesarean delivery
- Ages between 21-35 years
- Gestation ages ≥ 37 weeks and < 42 weeks
- Willing to comply with study dosing and completed the entire course of the study
- Willing to give and sign an informed consent form and a photographic release form
Key exclusion criteria (9 listed)
- Fibroids
- Placenta previa
- Placenta abruption
- Multiple gestation
- Antepartum hemorrhage
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 MSCsParticipants will receive direct local intramuscular injection of 1*10^7 MSCs (in 1ml of 0.9% saline) in the uterine incision. | Other | Umbilical cord MSCs Group |
Primary outcome
Safety evaluation through vital signs, the results of clinical lab tests and adverse events
Time frame: 6 months post treatment
Safety evaluation through vital signs, the results of clinical lab tests and adverse events.
7 secondary outcomes
Number of participants with uterine niche
Time frame: 6 months post treatment
Change of uterine scar thickness
Time frame: 6 weeks, 3 and 6 months post treatment
Change of uterine scar area
Time frame: 6 weeks, 3 and 6 months post treatment
Number of participants with endometritis
Time frame: 6 months post treatment
Number of participants with wound infection
Time frame: 6 months post treatment
Immunoglobulin concentrations in breast milk and serum
Time frame: 6 weeks, 3 and 6 months post treatment
Adverse events occurrence
Time frame: 6 months post treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Uterine Scar
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Recruiting
Platelet Rich Plasma for Uterine Scar
Cesarean Section Complications, Uterine Bleeding
Recruiting
Comparing Decidual Inclusion vs. Exclusion in Uterine Suture Techniques During Cesarean Section to Improve Scar Thickness and Reduce Isthmocele Risk in Primiparous Women
Isthmocele, Cesarean Scar Diverticula
Active, not recruiting
Comparison of Purse String Suture vs Transverse Mattress Suture to Maintain Hemostasis in Thinned-out Caesarean Sections Scars
Thinned-out Lower Uterine Segment Scar Previous Cesarean Section
Active, not recruitingObservational study
Transvaginal Electromechanical Fragmentation and Removal of Large Uterus in a Sealed Bag: The First Group of Clinical Studies Balancing Scar - Free and Anti - Dissemination
Uterine Fibroids, Adenomyosis
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.
Zhengping Liu, MD principal investigator
Maternal and Child Health Hospital of Foshan
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 Umbilical cord MSCs in people with Uterine Scar, run by Maternal and Child Health Hospital of Foshan 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 9 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: withdrawn, as of the sponsor's last update on 21 Dec 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
Safety evaluation through vital signs, the results of clinical lab tests and adverse events (time frame: 6 months post treatment). 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 21 Dec 2022.