Nasolabial FoldsPhase 1/2NCT03140319
Transplantation of Fibroblast for Correction of Nasolabial Folds
A Phase 1/2 study testing Fibroblast in people with Nasolabial Folds and Skin Aging, run by SCARM Institute, Tabriz, Iran at 1 site in Iran.
Trial summary
The study evaluated the safety and efficacy of the Autologous cultured fibroblast for correction of Nasolabial folds and inhibition of skin aging Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasolabial Folds, Skin Aging
- What is being tested?
- Fibroblast
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- 10 Dec 2020to 26 Dec 2021
- Phase
- Phase 1/2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Available and willing to attend all follow-up visits.
- Age > 18 years.
- Able and willing to give informed consent
Who cannot join
- Known allergy or sensitivity to any cellular products
- The subject has received a soft tissue augmentation to the area to be treated within the last 6 months.
- Subject is unwilling to forgo any cosmetic augmentation procedures for the duration of the study.
- The subject has received autologous fat transfer in the last 6 months.
- Subject is suffering from facial Kaposi's sarcoma.
- The subject has active skin diseases or inflammation on or near the area of injection
- positive HIV, hepatitis B virus (HBV), hepatitis C virus (HCV)
Trial locations and contacts
1 site in 1 country.
Iran1 site
Stem cell and Regenerative Medicine institute (SCARM)
Tabriz
Peyman Keyhanvar, Ph.D
Neda Keyhanvar, Ph.D
About this study
Official title: Autologous Transplantation of Cultured Fibroblast for Correction of Nasolabial Folds
The study evaluated the safety and efficacy of the Autologous cultured fibroblast for correction of Nasolabial folds and inhibition of skin aging
Read the detailed description
Autologous cultured fibroblast which is obtain from the patient's normal skin is harvested and expanded in an in vitro. Biopsies samples are obtained from the behind of the patient's ear as a source of fibroblasts, then fibroblast cells isolated and expanded through cell culture, and used for the correction of Nasolabial folds, deep wrinkles of the forehead. Prior to final packaging, cell viability is assessed to be at least 85%
- Conditions
- Nasolabial Folds, Skin Aging
- Being tested
- Fibroblast, Placebo
- Keywords
- Fibroblast, Cell transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibroblastBiological
Also called Autologous injection of Fibroblast
Transplantation of 20 million cell by three injection
PlaceboBiological
Injection of Placebo
| Study group | Role | What they receive |
|---|---|---|
| Fibroblast | Experimental | Injection of Fibroblast Receives: Biological: Fibroblast |
| Placebo | Placebo comparator | the patient receive placebo injection Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correction of Nasolabial
Evaluate the correction of skin changes after transplantation of autologous fibroblasts by medical examination
Measured: 6 months after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start10 Dec 2020 (estimated)
- Primary completion15 Nov 2021 (estimated)
- Study completion26 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Nasolabial FoldsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SCARM Institute, Tabriz, Iran
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Peyman Keyhanvar, MD, Ph.D, Study director, Deputy for translational medicine of SCARM instituteMohammad Nouri, Ph.D, Study chair, Head of SCARM instituteRaheleh Farahzadi, Ph.D, Principal investigator, cardiovascular research center, Tabriz University of Medical Sciences, Tabriz, IranSamira Asghari, MSc, Principal investigator, SCARM institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140319
- Sponsor's protocol ID
- SCARM-Skin-001
- Status last verified
- Jul 2020
- First submitted
- 2 May 2017
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weiss RA, Weiss MA, Beasley KL, Munavalli G. Autologous cultured fibroblast injection for facial contour deformities: a prospective, placebo-controlled, Phase III clinical trial. Dermatol Surg. 2007 Mar;33(3):263-8. doi: 10.1111/j.1524-4725.2007.33060.x.
PubMed 17338681Munavalli GS, Smith S, Maslowski JM, Weiss RA. Successful treatment of depressed, distensible acne scars using autologous fibroblasts: a multi-site, prospective, double blind, placebo-controlled clinical trial. Dermatol Surg. 2013 Aug;39(8):1226-36. doi: 10.1111/dsu.12204. Epub 2013 Apr 8.
PubMed 23566237Purdue GF, Hunt JL, Still JM Jr, Law EJ, Herndon DN, Goldfarb IW, Schiller WR, Hansbrough JF, Hickerson WL, Himel HN, Kealey GP, Twomey J, Missavage AE, Solem LD, Davis M, Totoritis M, Gentzkow GD. A multicenter clinical trial of a biosynthetic skin replacement, Dermagraft-TC, compared with cryopreserved human cadaver skin for temporary coverage of excised burn wounds. J Burn Care Rehabil. 1997 Jan-Feb;18(1 Pt 1):52-7. doi: 10.1097/00004630-199701000-00009.
PubMed 9063788Rigotti G, Charles-de-Sa L, Gontijo-de-Amorim NF, Takiya CM, Amable PR, Borojevic R, Benati D, Bernardi P, Sbarbati A. Expanded Stem Cells, Stromal-Vascular Fraction, and Platelet-Rich Plasma Enriched Fat: Comparing Results of Different Facial Rejuvenation Approaches in a Clinical Trial. Aesthet Surg J. 2016 Mar;36(3):261-70. doi: 10.1093/asj/sjv231.
PubMed 26879294
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Transplantation of Cultured Fibroblast for Correction of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT03140319
- Acronym / sponsor ID
- SCARM-Skin-001
- Conditions
- Nasolabial Folds, Skin Aging
- Keywords
- Fibroblast, Cell transplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- SCARM Institute, Tabriz, IranOther government
- Study start
- 10 Dec 2020 (estimated)
- Primary completion
- 15 Nov 2021 (estimated)
- Study completion
- 26 Dec 2021 (estimated)
- First posted
- 4 May 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 study evaluated the safety and efficacy of the Autologous cultured fibroblast for correction of Nasolabial folds and inhibition of skin aging
Detailed description
Autologous cultured fibroblast which is obtain from the patient's normal skin is harvested and expanded in an in vitro. Biopsies samples are obtained from the behind of the patient's ear as a source of fibroblasts, then fibroblast cells isolated and expanded through cell culture, and used for the correction of Nasolabial folds, deep wrinkles of the forehead. Prior to final packaging, cell viability is assessed to be at least 85%
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibroblast | Experimental | Biological: FibroblastInjection of Fibroblast |
| Placebo | Placebo comparator | Biological: Placebothe patient receive placebo injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Available and willing to attend all follow-up visits.
- Age > 18 years.
- Able and willing to give informed consent
Key exclusion criteria (7 listed)
- Known allergy or sensitivity to any cellular products
- The subject has received a soft tissue augmentation to the area to be treated within the last 6 months.
- Subject is unwilling to forgo any cosmetic augmentation procedures for the duration of the study.
- The subject has received autologous fat transfer in the last 6 months.
- Subject is suffering from facial Kaposi's sarcoma.
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 |
|---|---|---|
| FibroblastAlso: Autologous injection of FibroblastTransplantation of 20 million cell by three injection | Biological | Fibroblast |
| PlaceboInjection of Placebo | Biological | Placebo |
Primary outcome
Correction of Nasolabial
Time frame: 6 months after transplantation
Evaluate the correction of skin changes after transplantation of autologous fibroblasts by medical examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Results publication: PubMed 17338681Weiss RA, Weiss MA, Beasley KL, Munavalli G. Autologous cultured fibroblast injection for facial contour deformities: a prospective, placebo-controlled, Phase III clinical trial. Dermatol Surg. 2007 Mar;33(3):263-8. doi: 10.1111/j.1524-4725.2007.33060.x.
- Results publication: PubMed 23566237Munavalli GS, Smith S, Maslowski JM, Weiss RA. Successful treatment of depressed, distensible acne scars using autologous fibroblasts: a multi-site, prospective, double blind, placebo-controlled clinical trial. Dermatol Surg. 2013 Aug;39(8):1226-36. doi: 10.1111/dsu.12204. Epub 2013 Apr 8.
- Results publication: PubMed 9063788Purdue GF, Hunt JL, Still JM Jr, Law EJ, Herndon DN, Goldfarb IW, Schiller WR, Hansbrough JF, Hickerson WL, Himel HN, Kealey GP, Twomey J, Missavage AE, Solem LD, Davis M, Totoritis M, Gentzkow GD. A multicenter clinical trial of a biosynthetic skin replacement, Dermagraft-TC, compared with cryopreserved human cadaver skin for temporary coverage of excised burn wounds. J Burn Care Rehabil. 1997 Jan-Feb;18(1 Pt 1):52-7. doi: 10.1097/00004630-199701000-00009.
- Results publication: PubMed 26879294Rigotti G, Charles-de-Sa L, Gontijo-de-Amorim NF, Takiya CM, Amable PR, Borojevic R, Benati D, Bernardi P, Sbarbati A. Expanded Stem Cells, Stromal-Vascular Fraction, and Platelet-Rich Plasma Enriched Fat: Comparing Results of Different Facial Rejuvenation Approaches in a Clinical Trial. Aesthet Surg J. 2016 Mar;36(3):261-70. doi: 10.1093/asj/sjv231.
- Individual participant dataSharing planned: No
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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.
Peyman Keyhanvar, MD, Ph.D study director
Deputy for translational medicine of SCARM institute
Mohammad Nouri, Ph.D study chair
Head of SCARM institute
Raheleh Farahzadi, Ph.D principal investigator
cardiovascular research center, Tabriz University of Medical Sciences, Tabriz, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fibroblast in people with Nasolabial Folds and Skin Aging, run by SCARM Institute, Tabriz, Iran at 1 site in Iran.
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 7 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 27 Oct 2020. 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 Iran. 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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peyman Keyhanvar, MD, Ph.D (0914 114 6863, drkeyhanvar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correction of Nasolabial (time frame: 6 months after transplantation). 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 NCT03140319, which also lists 4 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 27 Oct 2020.