Nasolabial FoldsPhase 2NCT01115634
Autologous Fibroblast Transplantation in Facial Deformities
A Phase 2 study testing Fibroblast and fibroblast and gel in people with Nasolabial Folds and Glabellar Crease, run by Royan Institute at 1 site in Iran.
Trial summary
Beautiful skin requires maintenance of proper care. Skin exercise, protections from direct sunlight or harsh wind, and maintaining a healthy diet are some of the ways of having a good and radiant skin. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasolabial Folds, Glabellar Crease, Deep Wrinkles of the Forehead
- What is being tested?
- Fibroblast and fibroblast and gel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- Sep 2008to Nov 2015
- 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 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 collagen fillers
- 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, HBV, HCV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autologous Transplantation of Cultured Fibroblast for Facial Contour Deformities
Beautiful skin requires maintenance of proper care. Skin exercise, protections from direct sunlight or harsh wind, and maintaining a healthy diet are some of the ways of having a good and radiant skin. However despite all the care taken passage of time will bring about conditions that will automatically lead to skin aging, which may require certain therapeutic, care. Fibroblasts are cells that synthesize the extracellular matrix and collagen and play a critical role in wound healing and maintenance of healthy skin. Loosing of fibroblast cell is the main problem in aging and wrinkles and non-healed skin wounds. Therefore proliferation of skin fibroblast along with differentiation of stem cells in the skin tissue is the best method for healing.
Read the detailed description
Autologous cultured fibroblast is derived from in vitro expansion of fibroblasts harvested from the patient's normal skin. Biopsies from behind a patient's ear are the source of fibroblasts, which are isolated, expanded through cell culture, and used for the correction of facial contour deformities such as nasolabial folds, glabellar crease, deep wrinkles of the forehead, and acne scars. Prior to final packaging, cell viability is assessed to be at least 85%.
Each single use container of autologous cultured fibroblasts has approximately 20 million cells aseptically processed and suspended in 1 mL of sterile, buffered Dulbecco's Modified Eagles Medium (DMEM). Both the biopsy transport media and the cell culture media contain gentamicin. Residual quantities of gentamicin up to 5 µg/mL may be present in the Cell product
- Being tested
- Fibroblast, fibroblast and gel
- Keywords
- Fibroblast, Cell transplantation, Facial deformities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibroblastBiological
Also called cell alone
20 million cell in three injection
fibroblast and gelBiological
20 million cell in three injection plus filler
| Study group | Role | What they receive |
|---|---|---|
| Fibroblast | Experimental | Injection of autologous cultured fibroblast Receives: Biological: Fibroblast; Biological: fibroblast and gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-point shift in at least one treated area using a standardized 7-point photoguide
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 posted4 May 2010 (estimated)
- Study startSep 2008
- Primary completionSep 2015
- Study completionNov 2015
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 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Saeed Shafiyan, MD, Principal investigator, Royan InstituteNasser Aghdami, MD., PhD, Study director, Royan Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115634
- Sponsor's protocol ID
- Royan-skin-002
- Status last verified
- May 2010
- First submitted
- 1 May 2010
- Last updated
- 21 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Salehi Z, Shams-Ghahfarokhi M, Razzaghi-Abyaneh M. Internal Transcribed Spacer rDNA and TEF-1alpha Gene Sequencing of Pathogenic Dermatophyte Species and Differentiation of Closely Related Species Using PCR-RFLP of The Topoisomerase II. Cell J. 2020 Apr;22(1):85-91. doi: 10.22074/cellj.2020.6372. Epub 2019 Sep 8.
PubMed 31606971Bajouri A, Orouji Z, Taghiabadi E, Nazari A, Shahbazi A, Fallah N, Mohammadi P, Rezvani M, Jouyandeh Z, Vaezirad F, Khalajasadi Z, Ghasemi M, Fanni A, Haji Hosseinali S, Alizadeh A, Baharvand H, Shafieyan S, Aghdami N. Long-Term Follow-up of Autologous Fibroblast Transplantation for Facial Contour Deformities, A Non-Randomized Phase IIa Clinical Trial. Cell J. 2020 Apr;22(1):75-84. doi: 10.22074/cellj.2020.6340. Epub 2019 Sep 8.
PubMed 31606970
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Transplantation of Cultured Fibroblast for Facial Contour Deformities
- ClinicalTrials.gov ID
- NCT01115634
- Acronym / sponsor ID
- Royan-skin-002
- Keywords
- Fibroblast, Cell transplantation, Facial deformities
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Study start
- Sep 2008
- Primary completion
- Sep 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 4 May 2010 (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.
Beautiful skin requires maintenance of proper care. Skin exercise, protections from direct sunlight or harsh wind, and maintaining a healthy diet are some of the ways of having a good and radiant skin. However despite all the care taken passage of time will bring about conditions that will automatically lead to skin aging, which may require certain therapeutic, care. Fibroblasts are cells that synthesize the extracellular matrix and collagen and play a critical role in wound healing and maintenance of healthy skin. Loosing of fibroblast cell is the main problem in aging and wrinkles and non-healed skin wounds. Therefore proliferation of skin fibroblast along with differentiation of stem cells in the skin tissue is the best method for healing.
Detailed description
Autologous cultured fibroblast is derived from in vitro expansion of fibroblasts harvested from the patient's normal skin. Biopsies from behind a patient's ear are the source of fibroblasts, which are isolated, expanded through cell culture, and used for the correction of facial contour deformities such as nasolabial folds, glabellar crease, deep wrinkles of the forehead, and acne scars. Prior to final packaging, cell viability is assessed to be at least 85%.
Each single use container of autologous cultured fibroblasts has approximately 20 million cells aseptically processed and suspended in 1 mL of sterile, buffered Dulbecco's Modified Eagles Medium (DMEM). Both the biopsy transport media and the cell culture media contain gentamicin. Residual quantities of gentamicin up to 5 µg/mL may be present in the Cell product
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fibroblast | Experimental | Biological: Fibroblast, Biological: fibroblast and gelInjection of autologous cultured fibroblast |
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 collagen fillers
- 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: cell alone20 million cell in three injection | Biological | Fibroblast |
| fibroblast and gel20 million cell in three injection plus filler | Biological | Fibroblast |
Primary outcome
2-point shift in at least one treated area using a standardized 7-point photoguide
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 21 Jul 2016.
- Derived from this study: PubMed 31606971Salehi Z, Shams-Ghahfarokhi M, Razzaghi-Abyaneh M. Internal Transcribed Spacer rDNA and TEF-1alpha Gene Sequencing of Pathogenic Dermatophyte Species and Differentiation of Closely Related Species Using PCR-RFLP of The Topoisomerase II. Cell J. 2020 Apr;22(1):85-91. doi: 10.22074/cellj.2020.6372. Epub 2019 Sep 8.
- Derived from this study: PubMed 31606970Bajouri A, Orouji Z, Taghiabadi E, Nazari A, Shahbazi A, Fallah N, Mohammadi P, Rezvani M, Jouyandeh Z, Vaezirad F, Khalajasadi Z, Ghasemi M, Fanni A, Haji Hosseinali S, Alizadeh A, Baharvand H, Shafieyan S, Aghdami N. Long-Term Follow-up of Autologous Fibroblast Transplantation for Facial Contour Deformities, A Non-Randomized Phase IIa Clinical Trial. Cell J. 2020 Apr;22(1):75-84. doi: 10.22074/cellj.2020.6340. Epub 2019 Sep 8.
- Related InfoLink provided by the sponsor.
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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.
Saeed Shafiyan, MD principal investigator
Royan Institute
Nasser Aghdami, MD., PhD study director
Royan Institute
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 Fibroblast and fibroblast and gel in people with Nasolabial Folds and Glabellar Crease, run by Royan Institute 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: finished, as of the sponsor's last update on 21 Jul 2016. 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. 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?
2-point shift in at least one treated area using a standardized 7-point photoguide (time frame: 6 months). 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 NCT01115634, 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 21 Jul 2016.