Senescence Wrinkles, Acne, Pitting ScarPhase 1NCT02698813
Safety Study of Filler Agent Composed of Umbilical Cord Mesenchymal Stem Cells and Hyaluronic Acid
A Phase 1 study testing umbilical cord mesenchymal stem cells and hyaluronic acid and hyaluronic acid in people with Senescence Wrinkles, Acne, Pitting Scar, run by South China Research Center for Stem Cell and Regenerative Medicine.
Trial summary
The overall goal of this study is to evaluate the safety and exploratory efficacy of the injectable filler agent composed of umbilical cord mesenchymal stem cells and hyaluronic acid for the improvement of wrinkles, acne, pitting scar and so on. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Senescence Wrinkles, Acne, Pitting Scar
- What is being tested?
- umbilical cord mesenchymal stem cells and hyaluronic acid and hyaluronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2018
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female over 18 years;
- Have ability to understand and comply with the study requirements, and provide the written informed consent prior to any procedures ;
- Suitable for the medical history and physical examination like the following preoperative laboratory tests results: complete blood count, coagulation, biochemistry, electrocardiogram, hepatogram and β-human chorionic gonadotropin (hCG) for women of childbearing age.
Who cannot join
- Patients unable to undergo surgery liposuction with Klein technique as those with severe cardiovascular disease, severe coagulation disorders including thrombophilia and pregnancy;
- Have history or active dermal diseases, inflammation, or any related disease;
- Had invasive aesthetic treatments or surgeries history 6 months before the treatments;
- Had physical or chemical aesthetic treatments 1 months before the study starts;
- Have a known history of allergic reactions like hypersensitivity to hyaluronic acid;
- Patients with limited understanding of the procedure or have poor compliance with the study or follow-up schedule;
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- Pregnant or lactating;
- Use of drugs;
- Patients with preoperative results considered inadequate.
Trial locations and contacts
No sites are listed yet.
About this study
The overall goal of this study is to evaluate the safety and exploratory efficacy of the injectable filler agent composed of umbilical cord mesenchymal stem cells and hyaluronic acid for the improvement of wrinkles, acne, pitting scar and so on.
- Conditions
- Senescence Wrinkles, Acne, Pitting Scar
- Being tested
- umbilical cord mesenchymal stem cells and hyaluronic acid, hyaluronic acid
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
umbilical cord mesenchymal stem cells and hyaluronic acidBiological
hyaluronic acidDrug
| Study group | Role | What they receive |
|---|---|---|
| UCMSCs-HA | Experimental | Multipoint of Transdermal injection into the wrinkles. Injectable filler agent composed of umbilical cord mesenchymal stem cells (UCMSCs) and hyaluronic acid (HA). Receives: Biological: umbilical cord mesenchymal stem cells and hyaluronic acid |
| Control | Active comparator | Procedure: Transdermal injection of hyaluronic acid only. Receives: Drug: hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with non-serious and serious adverse events
Measured: Change from baseline up to week 12 after injection.
Secondary outcomes (2)
Wrinkle Severity Rating Scale (WSRS) Evaluation
An improvement was judged by the outcome of the preoperative grade minus the postoperative grade in accordance with the Wrinkle Severity Rating Scale (WSRS).The severity was measured using the Wrinkle Severity Rating Scale (WSRS), where 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Extreme, which is an ordinal scale.
Measured: Change from baseline at week 2, 6 and 12.
Global Aesthetic Improvement Scale (GAIS) Evaluation
An improvement was judged by the outcome of the preoperative grade minus the postoperative grade in accordance with the Global Aesthetic Improvement Scale (GAIS).
Measured: Change from baseline at week 2, 6 and 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Senescence Wrinkles, Acne, Pitting 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South China Research Center for Stem Cell and Regenerative Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02698813
- Sponsor's protocol ID
- UCMSC-HA-1
- Status last verified
- Feb 2016
- First submitted
- 4 Feb 2016
- Last updated
- 4 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study of Filler Agent Composed of Umbilical Cord Mesenchymal Stem Cells and Hyaluronic Acid
- ClinicalTrials.gov ID
- NCT02698813
- Acronym / sponsor ID
- UCMSC-HA-1
- Conditions
- Senescence Wrinkles, Acne, Pitting Scar
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- South China Research Center for Stem Cell and Regenerative MedicineUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2018 (estimated)
- First posted
- 4 Mar 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 overall goal of this study is to evaluate the safety and exploratory efficacy of the injectable filler agent composed of umbilical cord mesenchymal stem cells and hyaluronic acid for the improvement of wrinkles, acne, pitting scar and so on.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UCMSCs-HA | Experimental | Biological: umbilical cord mesenchymal stem cells and hyaluronic acidMultipoint of Transdermal injection into the wrinkles. Injectable filler agent composed of umbilical cord mesenchymal stem cells (UCMSCs) and hyaluronic acid (HA). |
| Control | Active comparator | Drug: hyaluronic acidProcedure: Transdermal injection of hyaluronic acid only. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female over 18 years;
- Have ability to understand and comply with the study requirements, and provide the written informed consent prior to any procedures ;
- Suitable for the medical history and physical examination like the following preoperative laboratory tests results: complete blood count, coagulation, biochemistry, electrocardiogram, hepatogram and β-human chorionic gonadotropin (hCG) for women of childbearing age.
Key exclusion criteria (9 listed)
- Patients unable to undergo surgery liposuction with Klein technique as those with severe cardiovascular disease, severe coagulation disorders including thrombophilia and pregnancy;
- Have history or active dermal diseases, inflammation, or any related disease;
- Had invasive aesthetic treatments or surgeries history 6 months before the treatments;
- Had physical or chemical aesthetic treatments 1 months before the study starts;
- Have a known history of allergic reactions like hypersensitivity to hyaluronic acid;
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 and hyaluronic acid | Biological | UCMSCs-HA |
| hyaluronic acid | Drug | Control |
Primary outcome
Proportion of patients with non-serious and serious adverse events
Time frame: Change from baseline up to week 12 after injection.
2 secondary outcomes
Wrinkle Severity Rating Scale (WSRS) Evaluation
Time frame: Change from baseline at week 2, 6 and 12.
Global Aesthetic Improvement Scale (GAIS) Evaluation
Time frame: Change from baseline at week 2, 6 and 12.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2016.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing umbilical cord mesenchymal stem cells and hyaluronic acid and hyaluronic acid in people with Senescence Wrinkles, Acne, Pitting Scar, run by South China Research Center for Stem Cell and Regenerative Medicine.
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 3 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: status not confirmed, as of the sponsor's last update on 4 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuetao Pei, M.D., Ph.D (8610-68164807, AMMS0906@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with non-serious and serious adverse events (time frame: Change from baseline up to week 12 after injection.). 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 4 Mar 2016.