CicatrixPhase 2NCT04034615
The Long-term Effect of 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 long-term efficacy 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
- 0 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2021to 1 Jun 2022
- 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, Placebo-Controlled Study of the Long-term Efficacy of Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars
The study is to investigate the long-term efficacy 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
This trial is a continuation of the investigators' previous clinical trial (NCT02772289). In the previous three-arm randomized clinical trial involving women with primiparous singleton pregnancies, the investigators found umbilical cord mesenchymal stem cells was not significantly different from placebo for the reduction of cesarean section skin scar and did not increase recognition of participants'satisfaction at the sixth month follow-up. Although there was no statistical difference, the trial study found that the total vancouver scar scale rating was lower with the dose increased.
Some studies have suggested that it usually took 18-24 months for a typical scar matures. In this trial, the investigators want to continue to investigate the efficacy of perinatal tissue mesenchyme stem cells treatment on the appearance of a caesarean scar as compared to a similar untreated scar at the three years follow-up.
- 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.
Vancouver Scar Scale score
The investigators measured scar at three years post treatment using Vancouver Scar Scale (VSS). The VSS included vascularity (normal, pink, red, or purple), pigmentation (normal, hypopigmented, mixed, or hyperpigmented), height (flat, < 2 mm, 2-5 mm, or > 5 mm), and pliability (normal, supple, yielding, firm, ropes, or contracture). Each variable contained ranked subscales that could be summed to obtain a total score ranging from 0 to 14, with 0 representing normal skin and a higher score representing a more marked or abnormal scar. The Chinese version of the VSS has been shown to have good intraclass correlations and Cronbach's α measures. All scars will be assessed independently by two observers on the same day when the participants are lying in a supine position with the scar exposed in bright light. If the data varies, another researcher will be required to assess the scar at the same day and the results with the highest frequency will be recorded.
Measured: Three years post treatment
Secondary outcomes (4)
Erythema
measured by reflectance
Measured: Three years post treatment
Pigmentation
measured by reflectance
Measured: Three years 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: Three years post treatment
Subject's satisfaction
Subject's satisfaction of the treatment using a Satisfaction Scale as follows: None; Slight; Moderate; Good; Very Good.
Measured: Three years post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start20 May 2021
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Jun 2022 (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 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- 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
- NCT04034615
- Sponsor's protocol ID
- MCHHFoshan-1902
- Status last verified
- Dec 2022
- First submitted
- 24 Jul 2019
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 II, Randomized, Placebo-Controlled Study of the Long-term Efficacy of Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars
- ClinicalTrials.gov ID
- NCT04034615
- Acronym / sponsor ID
- MCHHFoshan-1902
- Conditions
- Cicatrix
- Keywords
- Mesenchyme Stem Cells, Cesarean Section, Scars
- Phase
- Phase 2
- 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
- 20 May 2021 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 26 Jul 2019 (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 study is to investigate the long-term efficacy of perinatal tissue mesenchyme stem cells treatment on the appearance of a caesarean scar as compared to a similar untreated scar.
Detailed description
This trial is a continuation of the investigators' previous clinical trial (NCT02772289). In the previous three-arm randomized clinical trial involving women with primiparous singleton pregnancies, the investigators found umbilical cord mesenchymal stem cells was not significantly different from placebo for the reduction of cesarean section skin scar and did not increase recognition of participants'satisfaction at the sixth month follow-up. Although there was no statistical difference, the trial study found that the total vancouver scar scale rating was lower with the dose increased.
Some studies have suggested that it usually took 18-24 months for a typical scar matures. In this trial, the investigators want to continue to investigate the efficacy of perinatal tissue mesenchyme stem cells treatment on the appearance of a caesarean scar as compared to a similar untreated scar at the three years follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, 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
Vancouver Scar Scale score
Time frame: Three years post treatment
The investigators measured scar at three years post treatment using Vancouver Scar Scale (VSS). The VSS included vascularity (normal, pink, red, or purple), pigmentation (normal, hypopigmented, mixed, or hyperpigmented), height (flat, < 2 mm, 2-5 mm, or > 5 mm), and pliability (normal, supple, yielding, firm, ropes, or contracture). Each variable contained ranked subscales that could be summed to obtain a total score ranging from 0 to 14, with 0 representing normal skin and a higher score representing a more marked or abnormal scar. The Chinese version of the VSS has been shown to have good intraclass correlations and Cronbach's α measures. All scars will be assessed independently by two observers on the same day when the participants are lying in a supine position with the scar exposed in bright light. If the data varies, another researcher will be required to assess the scar at the same day and the results with the highest frequency will be recorded.
4 secondary outcomes
Erythema
Time frame: Three years post treatment
Pigmentation
Time frame: Three years post treatment
Scar Thickness and Uniformity
Time frame: Three years post treatment
Subject's satisfaction
Time frame: Three years 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.
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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: 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. 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 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?
Vancouver Scar Scale score (time frame: Three years 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.