CicatrixPhase 2NCT02772289
Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars
A Phase 2 study testing Mesenchyme Stem Cells low-dose group and Mesenchyme Stem Cells high-dose group in people with Cicatrix, run by Maternal and Child Health Hospital of Foshan at 1 site in China.
Trial summary
The study is to investigate the efficacy and safety of perinatal tissue mesenchyme stem cells treatment on the appearance of a caesarean scar as compared to a similar untreated scar. 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
- Cicatrix
- What is being tested?
- Mesenchyme Stem Cells low-dose group and Mesenchyme Stem Cells high-dose group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Mar 2019
- Phase
- Phase 2
- 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 give and sign an informed consent form and a photographic release form
- Willing to comply with study dosing and complete the entire course of the study
Who cannot join
- Any systemic uncontrolled disease
- Recent or current cancer
- History or presenting with a keloid formation
- Wounds or local disease in treatment area
- Planning any other cosmetic procedure to the study area during the study period
- Smoking
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 II, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars
The study is to investigate the efficacy and safety of perinatal tissue mesenchyme stem cells treatment on the appearance of a caesarean scar as compared to a similar untreated scar.
Read the detailed description
Nowadays, cesarean is one of the most common surgical interventions and its prevalence has increased in most countries in the recent years. Delay in healing of cesarean wound and formation of visible scar are common symptoms of maternal morbidity after cesarean section. These complications affect mother's quality of life due to stress, anxiety, delay in mother's ability and health recovery, and also they are associated with additional cost as a result of the increased need for wide spectrum antibiotics and sometimes hospitalization and repeated repair of wound. Improve the final aspect of would and visible scars, have been a challenge for medicine. Mesenchymal stem cells (MSC) are a population of pluripotent stem cells that are self-renewing and capable of differentiating into canonical cells of the mesenchyme. Recently, stem cells have been applied to regenerative medicine, even for internal organs such as blood vessels, nerves, and heart.
The study is to investigate the efficacy and safety of perinatal tissue mesenchyme stem cells treatment on the appearance of a caesarean scar as compared to a similar untreated scar. This is a randomized, double-blind, placebo-controlled clinical trial designed to investigate the efficacy and safety of perinatal tissue mesenchyme stem cells (MSC) treatment on the appearance of a caesarean scar as compared to a similar untreated scar. A total of ninety (90) participants will be randomized (1:1:1) to receive MSC or placebo. All of participants will be undergoing delivery by lower segment caesarean section through a transverse abdominal incision, and there will be no clear indication for a particular surgical technique or material to be used. In low-dose MSC group, participants will receive transdermal one dose of 1*10^6 cells of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous three days and then receive transdermal placebo without of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous next three days; In high-dose MSC group, participants will receive transdermal one dose of 1*10^6 cells of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous six days; And in placebo group, participants will receive transdermal placebo without of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous six days. After randomization, baseline data, and transdermal treatment, participants will be followed up at 1 month, 3 months and 6 months. For the purpose of the endpoint analysis and safety evaluations, the investigators will utilize an "intention-to-treat" study population.
- Conditions
- Cicatrix
- Being tested
- Mesenchyme Stem Cells low-dose group, Mesenchyme Stem Cells high-dose group, Placebo
- Keywords
- Mesenchyme Stem Cells, Cesarean Section, Scars
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchyme Stem Cells low-dose groupBiological
Participants will receive transdermal one dose of 1*10^6 cells of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous three days and then receive transdermal placebo without of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous next three days.
Mesenchyme Stem Cells high-dose groupBiological
Participants will receive transdermal one dose of 1*10^6 cells of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous six days.
PlaceboBiological
Participants will receive transdermal placebo without of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous six days.
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal Stem Cells low-dose group | Experimental | Target dose of 3 million Mesenchymal Stem Cells Receives: Biological: Mesenchyme Stem Cells low-dose group |
| Mesenchymal Stem Cells high-dose group | Experimental | Target dose of 6 million Mesenchymal Stem Cells Receives: Biological: Mesenchyme Stem Cells high-dose group |
| Placebo | Placebo comparator | Placebo without Mesenchyme Stem Cells Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Vancouver Scar Scale (VSS)
The investigators measured quartile grading scale at 1st, 3rd and 6th months of study and evaluated the change of the scale
Measured: 1st, 3rd, 6th month post treatment
Secondary outcomes (8)
Wound healing status
Wound healing status was assessed using REEDA scale which is based on the amount of redness, edema, ecchymosis, discharge and the approximation of wound edges (each one scored between 0-3); the final score was the sum of the items scores. Lower score indicated better healing.
Measured: 14 days post surgery
Erythema measured by reflectance
measured by reflectance
Measured: 1st, 3rd, 6th month post treatment
Pigmentation measured by reflectance
measured by reflectance
Measured: 1st, 3rd, 6th months post treatment
Scar Thickness and Uniformity
A High Definition Ultrasound (US) device will be used to generate a high resolution image of the skin layers of the treated and non-treated scar in order to measure and compare changes in scar thickness and uniformity.
Measured: 1st, 3rd, 6th month post treatment
Change of scar area
A High Definition Ultrasound (US) device will be used to generate a high resolution image of the skin layers of the treated and non-treated scar in order to measure and compare changes in scar area.
Measured: 1st, 3rd, 6th month post treatment
Immunoglobulin concentrations in breast milk
Breast milk immunoglobulin (IgG, IgA, IgM) and the complement (C3, C4) were detected by transmission immune turbidity method using automatic biochemical analyzer.
Measured: 1st, 3rd, 6th month post treatment
Subject's satisfaction
Subject's satisfaction of the treatment using a Satisfaction Scale as follows: None; Slight; Moderate; Good; Very Good.
Measured: 6th month 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startNov 2016
- Primary completionSep 2018
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CicatrixStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 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
- NCT02772289
- Sponsor's protocol ID
- MCHHFoshan-1602
- Status last verified
- May 2019
- First submitted
- 10 May 2016
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Fan D, Zeng M, Xia Q, Wu S, Ye S, Rao J, Lin D, Zhang H, Ma H, Han Z, Guo X, Liu Z. Efficacy and safety of umbilical cord mesenchymal stem cells in treatment of cesarean section skin scars: a randomized clinical trial. Stem Cell Res Ther. 2020 Jun 25;11(1):244. doi: 10.1186/s13287-020-01695-7.
PubMed 32586366Fan D, Xia Q, Wu S, Ye S, Liu L, Wang W, Guo X, Liu Z. Mesenchymal stem cells in the treatment of Cesarean section skin scars: study protocol for a randomized, controlled trial. Trials. 2018 Mar 2;19(1):155. doi: 10.1186/s13063-018-2478-x.
PubMed 29499740
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars
- ClinicalTrials.gov ID
- NCT02772289
- Acronym / sponsor ID
- MCHHFoshan-1602
- Conditions
- Cicatrix
- Keywords
- Mesenchyme Stem Cells, Cesarean Section, Scars
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Maternal and Child Health Hospital of FoshanUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 13 May 2016 (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.
The study is to investigate the efficacy and safety of perinatal tissue mesenchyme stem cells treatment on the appearance of a caesarean scar as compared to a similar untreated scar.
Detailed description
Nowadays, cesarean is one of the most common surgical interventions and its prevalence has increased in most countries in the recent years. Delay in healing of cesarean wound and formation of visible scar are common symptoms of maternal morbidity after cesarean section. These complications affect mother's quality of life due to stress, anxiety, delay in mother's ability and health recovery, and also they are associated with additional cost as a result of the increased need for wide spectrum antibiotics and sometimes hospitalization and repeated repair of wound. Improve the final aspect of would and visible scars, have been a challenge for medicine. Mesenchymal stem cells (MSC) are a population of pluripotent stem cells that are self-renewing and capable of differentiating into canonical cells of the mesenchyme. Recently, stem cells have been applied to regenerative medicine, even for internal organs such as blood vessels, nerves, and heart.
The study is to investigate the efficacy and safety of perinatal tissue mesenchyme stem cells treatment on the appearance of a caesarean scar as compared to a similar untreated scar. This is a randomized, double-blind, placebo-controlled clinical trial designed to investigate the efficacy and safety of perinatal tissue mesenchyme stem cells (MSC) treatment on the appearance of a caesarean scar as compared to a similar untreated scar. A total of ninety (90) participants will be randomized (1:1:1) to receive MSC or placebo. All of participants will be undergoing delivery by lower segment caesarean section through a transverse abdominal incision, and there will be no clear indication for a particular surgical technique or material to be used. In low-dose MSC group, participants will receive transdermal one dose of 1*10^6 cells of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous three days and then receive transdermal placebo without of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous next three days; In high-dose MSC group, participants will receive transdermal one dose of 1*10^6 cells of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous six days; And in placebo group, participants will receive transdermal placebo without of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous six days. After randomization, baseline data, and transdermal treatment, participants will be followed up at 1 month, 3 months and 6 months. For the purpose of the endpoint analysis and safety evaluations, the investigators will utilize an "intention-to-treat" study population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal Stem Cells low-dose group | Experimental | Biological: Mesenchyme Stem Cells low-dose groupTarget dose of 3 million Mesenchymal Stem Cells |
| Mesenchymal Stem Cells high-dose group | Experimental | Biological: Mesenchyme Stem Cells high-dose groupTarget dose of 6 million Mesenchymal Stem Cells |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo without Mesenchyme Stem Cells |
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 give and sign an informed consent form and a photographic release form
- Willing to comply with study dosing and complete the entire course of the study
Key exclusion criteria (6 listed)
- Any systemic uncontrolled disease
- Recent or current cancer
- History or presenting with a keloid formation
- Wounds or local disease in treatment area
- Planning any other cosmetic procedure to the study area during the study period
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 |
|---|---|---|
| Mesenchyme Stem Cells low-dose groupParticipants will receive transdermal one dose of 1*10^6 cells of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous three days and then receive transdermal placebo without of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous next three days. | Biological | Mesenchymal Stem Cells low-dose group |
| Mesenchyme Stem Cells high-dose groupParticipants will receive transdermal one dose of 1*10^6 cells of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous six days. | Biological | Mesenchymal Stem Cells high-dose group |
| PlaceboParticipants will receive transdermal placebo without of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous six days. | Biological | Placebo |
Primary outcome
Change of Vancouver Scar Scale (VSS)
Time frame: 1st, 3rd, 6th month post treatment
The investigators measured quartile grading scale at 1st, 3rd and 6th months of study and evaluated the change of the scale
8 secondary outcomes
Wound healing status
Time frame: 14 days post surgery
Erythema measured by reflectance
Time frame: 1st, 3rd, 6th month post treatment
Pigmentation measured by reflectance
Time frame: 1st, 3rd, 6th months post treatment
Scar Thickness and Uniformity
Time frame: 1st, 3rd, 6th month post treatment
Change of scar area
Time frame: 1st, 3rd, 6th month post treatment
Immunoglobulin concentrations in breast milk
Time frame: 1st, 3rd, 6th month post treatment
Subject's satisfaction
Time frame: 6th month post treatment
Adverse events occurrence
Time frame: 6 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 7 May 2019.
- Derived from this study: PubMed 32586366Fan D, Zeng M, Xia Q, Wu S, Ye S, Rao J, Lin D, Zhang H, Ma H, Han Z, Guo X, Liu Z. Efficacy and safety of umbilical cord mesenchymal stem cells in treatment of cesarean section skin scars: a randomized clinical trial. Stem Cell Res Ther. 2020 Jun 25;11(1):244. doi: 10.1186/s13287-020-01695-7.
- Derived from this study: PubMed 29499740Fan D, Xia Q, Wu S, Ye S, Liu L, Wang W, Guo X, Liu Z. Mesenchymal stem cells in the treatment of Cesarean section skin scars: study protocol for a randomized, controlled trial. Trials. 2018 Mar 2;19(1):155. doi: 10.1186/s13063-018-2478-x.
- Individual participant dataSharing planned: Undecided
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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.
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 2 study testing Mesenchyme Stem Cells low-dose group and Mesenchyme Stem Cells high-dose group in people with Cicatrix, 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 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 7 May 2019. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change of Vancouver Scar Scale (VSS) (time frame: 1st, 3rd, 6th month post treatment). 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 NCT02772289, which also lists 2 linked publications.
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 7 May 2019.