Skin RejuvenationPhase 1NCT06217627
Skin Rejuvenation Using Stem Cell Secretome
A Phase 1 study testing secretome in people with Skin Rejuvenation, run by COR clinic of Regenerative Medicine at 1 site in Lebanon.
Trial summary
This clinical trial aims to investigate the effect of umbilical cord explants (UC)-explants and UC-mesenchymal stem cells (MSCs) secretome on skin rejuvenation, to provide future reference or standard in the application of cell free-based therapy in skin aging. Read more about this study
- Who is it for?
- Ages 25 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Rejuvenation
- What is being tested?
- secretome
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteLebanon
- Study dates
- 5 Mar 2021to 30 Jun 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 25 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women participants aged > 25 years
- any skin type according to the Glogau scale
- Willing to be a research subject, sign a consent form, and commit to follow-up visits
Who cannot join
- patients with active skin diseases (e.g. atopic dermatitis, psoriasis, rosacea, seborrheic dermatitis)
- patients using other anti-aging treatments within 1 month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Potential of Umbilical Cord Stem Cell Secretions in Skin Rejuvenation
This clinical trial aims to investigate the effect of umbilical cord explants (UC)-explants and UC-mesenchymal stem cells (MSCs) secretome on skin rejuvenation, to provide future reference or standard in the application of cell free-based therapy in skin aging.
Read the detailed description
This trial is a pilot clinical trial evaluating the effect of the secretions of umbilical cord explants and mesenchymal stem cells on skin rejuvenation. Also the concentration of selected growth factors was assessed in the secretome derived from UC-explants and UC-MSCs.
Healthy women participants, after their consent, received secretome injections in their hands, face, and neck. Outcomes were assessed on the Hand Volume Rating Scale, Wrinkle Severity Rating Scale, and through histologic examination of skin biopsy at two different times: before treatment and after 12 months. A digital camera was used to obtain photographs of hands, face, and Neck at each visit. These were assessed by a single-blinded dermatologist. SPSS software version 26 (64-bit) was used for all analyses.
Participants provided written informed consent and were asked not to change their routine skin care habits during the study.
- Conditions
- Skin Rejuvenation
- Being tested
- secretome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
secretomeBiological
The secretome is the secretions of MSCs or explants from umbilical cord tissues. It contains diverse trophic molecules including cytokines, chemokines, angiogenic factors, and growth factors.
| Study group | Role | What they receive |
|---|---|---|
| Umbilical cord (UC)- mesenchymal stem cells (MSCs) secretome | Experimental | 19 participants received UC-MSCs secretome injections in the neck and different areas of the face including the forehead, cheeks, under eyes, chin, and nasolabial folds. Receives: Biological: secretome |
| UC-explants secretome | Experimental | 30 participants received UC-explants secretome in the left and right hands Receives: Biological: secretome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Selected growth factors assessment
assessment of the concentration (pg/ml) of selected growth factors (bFGF, HGF, TIMP-3, VEGF, andTGF-b) in the secretome derived from UC-explants and UC-MSCs using ELISA essays.
Measured: 4 samples of secretome extracted from UC-explants with one week interval. 1 sample of secretome extracted from confluent UC-MSCs at passage 1
Wrinkle severity in hands
wrinkle severity was assessed in the hands by the Hand Volume Rating Scale: grade 0 (absent) to grade 4 (severe)
Measured: digital photographs before injection and after 7 months.
Wrinkle severity in the face and neck
wrinkle severity was assessed by the Wrinkle Severity Rating Scale: grade 0 (no wrinkles) to grade 5 ((very deep wrinkle and redundant fold)
Measured: digital photographs before injection and after 7 months.
Secondary outcomes (1)
Histological examination
The histological examination of skin biopsies evaluated the assessment of collagen, keratin, elastin, basement membrane of blood vessels, and fibroblast nuclei.
Measured: skin biopsies were performed at two moments: before treatment and after 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start5 Mar 2021
- Primary completion25 Jan 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin RejuvenationStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- COR clinic of Regenerative Medicine
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Nada Alaaeddine, Modern University for Business and Science
- Investigators
- Nada Alaaeddine, PhD, Principal investigator, COR clinic of Regenerative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217627
- Sponsor's protocol ID
- S2021-cor001
- Status last verified
- Feb 2024
- First submitted
- 10 Jan 2024
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential of Umbilical Cord Stem Cell Secretions in Skin Rejuvenation
- ClinicalTrials.gov ID
- NCT06217627
- Acronym / sponsor ID
- S2021-cor001
- Conditions
- Skin Rejuvenation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- COR clinic of Regenerative MedicineResearch network
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 22 Jan 2024 (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.
This clinical trial aims to investigate the effect of umbilical cord explants (UC)-explants and UC-mesenchymal stem cells (MSCs) secretome on skin rejuvenation, to provide future reference or standard in the application of cell free-based therapy in skin aging.
Detailed description
This trial is a pilot clinical trial evaluating the effect of the secretions of umbilical cord explants and mesenchymal stem cells on skin rejuvenation. Also the concentration of selected growth factors was assessed in the secretome derived from UC-explants and UC-MSCs.
Healthy women participants, after their consent, received secretome injections in their hands, face, and neck. Outcomes were assessed on the Hand Volume Rating Scale, Wrinkle Severity Rating Scale, and through histologic examination of skin biopsy at two different times: before treatment and after 12 months. A digital camera was used to obtain photographs of hands, face, and Neck at each visit. These were assessed by a single-blinded dermatologist. SPSS software version 26 (64-bit) was used for all analyses.
Participants provided written informed consent and were asked not to change their routine skin care habits during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Umbilical cord (UC)- mesenchymal stem cells (MSCs) secretome | Experimental | Biological: secretome19 participants received UC-MSCs secretome injections in the neck and different areas of the face including the forehead, cheeks, under eyes, chin, and nasolabial folds. |
| UC-explants secretome | Experimental | Biological: secretome30 participants received UC-explants secretome in the left and right hands |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- women participants aged > 25 years
- any skin type according to the Glogau scale
- Willing to be a research subject, sign a consent form, and commit to follow-up visits
Key exclusion criteria (2 listed)
- patients with active skin diseases (e.g. atopic dermatitis, psoriasis, rosacea, seborrheic dermatitis)
- patients using other anti-aging treatments within 1 month
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 |
|---|---|---|
| secretomeThe secretome is the secretions of MSCs or explants from umbilical cord tissues. It contains diverse trophic molecules including cytokines, chemokines, angiogenic factors, and growth factors. | Biological | UC-explants secretome, Umbilical cord (UC)- mesenchymal stem cells (MSCs) secretome |
Primary outcome
Selected growth factors assessment
Time frame: 4 samples of secretome extracted from UC-explants with one week interval. 1 sample of secretome extracted from confluent UC-MSCs at passage 1
assessment of the concentration (pg/ml) of selected growth factors (bFGF, HGF, TIMP-3, VEGF, andTGF-b) in the secretome derived from UC-explants and UC-MSCs using ELISA essays.
Wrinkle severity in hands
Time frame: digital photographs before injection and after 7 months.
wrinkle severity was assessed in the hands by the Hand Volume Rating Scale: grade 0 (absent) to grade 4 (severe)
Wrinkle severity in the face and neck
Time frame: digital photographs before injection and after 7 months.
wrinkle severity was assessed by the Wrinkle Severity Rating Scale: grade 0 (no wrinkles) to grade 5 ((very deep wrinkle and redundant fold)
1 secondary outcome
Histological examination
Time frame: skin biopsies were performed at two moments: before treatment and after 12 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 6 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Skin Rejuvenation
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Systemic and Topical Geroprotective Rejuvenation Assessed by START/REST Aging Clocks
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Objective Evaluation of Intradermal MSC-Derived Exosome Therapy on Facial Skin Quality
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Evaluation of SofWave Sofware-Guided Energy Delivery for Lower Face and Neck Rejuvenation
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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.
Nada Alaaeddine, PhD principal investigator
COR clinic of Regenerative Medicine
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 secretome in people with Skin Rejuvenation, run by COR clinic of Regenerative Medicine at 1 site in Lebanon.
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 2 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 6 Feb 2024. 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 Lebanon. 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 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?
Selected growth factors assessment (time frame: 4 samples of secretome extracted from UC-explants with one week interval. 1 sample of secretome extracted from confluent UC-MSCs at passage 1). The study lists 3 primary outcomes in all. 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 6 Feb 2024.