Temporomandibular Joint DisordersPhase 1/2NCT05305833
Stem Cells and Stromal Vascular Fraction for Temporomandibular Joint Disease
A Phase 1/2 study testing Stem Cells in people with Temporomandibular Joint Disorders and Temporomandibular Disorder, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
It will be evaluate the safety of mesenchymal stem cells and adipose tissue derived stromal vascular fraction (SVF) in temporomandibular joint disease cases. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temporomandibular Joint Disorders, Temporomandibular Disorder, Temporomandibular Joint Osteoarthritis
- What is being tested?
- Stem Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2021to 1 Dec 2023
- 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
- Chronic temporomandibular arthritic disorder
- History of pain and joint noises for at least 3 months
- Must have more than VAS 5 TMJ pain
- must have internal derangement of TMJ
- Limited mouth opening
- Magnetic resonance imaging evidence of effusion or degeneration
- Already treated with conservative methods (occlusal splint,pharmacological and/or physio-kinesio therapy) without satisfactory benefit.
Who cannot join
- Cancer patients
- Immunosupressed patients
- Previous TMJ traumas and fractures
- Previous TMJ surgeries
- TMJ ankylosis
Trial locations and contacts
1 site in 1 country.
Genkok center contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erciyes University
Kayseri, 38039
Genkok Center, 00903522076666 ext. 13600
ALPER KEMALOGLU, MD
About this study
Official title: Stem Cells Transplantation for Temporomandibular Joint Disease: Phase I/II Study
It will be evaluate the safety of mesenchymal stem cells and adipose tissue derived stromal vascular fraction (SVF) in temporomandibular joint disease cases.
Read the detailed description
umbilical cord derived mesenchymal stem cells produced under GMP facility in Erciyes University and SVF produced in operation theatre.
- Conditions
- Temporomandibular Joint Disorders, Temporomandibular Disorder, Temporomandibular Joint Osteoarthritis, Temporomandibular Joint Pain, Temporomandibular Joint Effusion
- Being tested
- Stem Cells
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem CellsBiological
ATMP
| Study group | Role | What they receive |
|---|---|---|
| umbilical cord derived mesenchymal stem cells transplantation group | Experimental | taking umbilical cord derived mesenchymal stem cells Receives: Biological: Stem Cells |
| stromal vascular fraction cells application group | Experimental | taking stromal vascular fraction cells Receives: Biological: Stem Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Pain at 15th day
using by Visual Analogue Scale (VAS); higher scores mean worse outcome
Measured: 15th day
Change from baseline maximum mouth opening at 15th day
the distance between incisal edge of maxillary central incisor to the incisal edge of mandibular central incisor, when the mouth is opened as wide as possible painlessly
Measured: 15th day
Change from baseline maximum mouth opening at 1 month
the distance between incisal edge of maxillary central incisor to the incisal edge of mandibular central incisor, when the mouth is opened as wide as possible painlessly at first month; higher scores means a better outcome
Measured: 1. month
Change from baseline maximum mouth opening at 3 months
the distance between incisal edge of maxillary central incisor to the incisal edge of mandibular central incisor, when the mouth is opened as wide as possible painlessly at third month; higher scores means a better outcome
Measured: 3. month
Change from baseline maximum mouth opening at 6 months
the distance between incisal edge of maxillary central incisor to the incisal edge of mandibular central incisor, when the mouth is opened as wide as possible painlessly at 6th month,higher scores means a better outcome
Measured: 6. month
Change from baseline pain at 1 month
using by Visual Analogue Scale (VAS)
Measured: 1. month
Change from baseline pain at 3 month
using by Visual Analogue Scale (VAS)
Measured: 3. month
Change from baseline pain at 6 month
using by Visual Analogue Scale (VAS) higher scores mean worse outcome
Measured: 6. month
Secondary outcomes (1)
Change from baseline 'comfort ' at 6th month
using by Visual Analogue Scale (VAS); higher scores mean better outcome
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 posted31 Mar 2022
- Study start1 Oct 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Burcin GONEN, TC Erciyes University
- Investigators
- Zeynep B Gonen, DDS,PHD, Principal investigator, Assoc.Prof
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305833
- Sponsor's protocol ID
- 2021/584
- Status last verified
- Mar 2022
- First submitted
- 12 Nov 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stem Cells Transplantation for Temporomandibular Joint Disease: Phase I/II Study
- ClinicalTrials.gov ID
- NCT05305833
- Acronym / sponsor ID
- 2021/584
- Conditions
- Temporomandibular Joint Disorders, Temporomandibular Disorder, Temporomandibular Joint Osteoarthritis, Temporomandibular Joint Pain, Temporomandibular Joint Effusion
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 31 Mar 2022 (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.
It will be evaluate the safety of mesenchymal stem cells and adipose tissue derived stromal vascular fraction (SVF) in temporomandibular joint disease cases.
Detailed description
umbilical cord derived mesenchymal stem cells produced under GMP facility in Erciyes University and SVF produced in operation theatre.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| umbilical cord derived mesenchymal stem cells transplantation group | Experimental | Biological: Stem Cellstaking umbilical cord derived mesenchymal stem cells |
| stromal vascular fraction cells application group | Experimental | Biological: Stem Cellstaking stromal vascular fraction cells |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Chronic temporomandibular arthritic disorder
- History of pain and joint noises for at least 3 months
- Must have more than VAS 5 TMJ pain
- must have internal derangement of TMJ
- Limited mouth opening
Key exclusion criteria (5 listed)
- Cancer patients
- Immunosupressed patients
- Previous TMJ traumas and fractures
- Previous TMJ surgeries
- TMJ ankylosis
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 |
|---|---|---|
| Stem CellsATMP | Biological | stromal vascular fraction cells application group, umbilical cord derived mesenchymal stem cells transplantation group |
Primary outcome
Change from Baseline Pain at 15th day
Time frame: 15th day
using by Visual Analogue Scale (VAS); higher scores mean worse outcome
Change from baseline maximum mouth opening at 15th day
Time frame: 15th day
the distance between incisal edge of maxillary central incisor to the incisal edge of mandibular central incisor, when the mouth is opened as wide as possible painlessly
Change from baseline maximum mouth opening at 1 month
Time frame: 1. month
the distance between incisal edge of maxillary central incisor to the incisal edge of mandibular central incisor, when the mouth is opened as wide as possible painlessly at first month; higher scores means a better outcome
Change from baseline maximum mouth opening at 3 months
Time frame: 3. month
the distance between incisal edge of maxillary central incisor to the incisal edge of mandibular central incisor, when the mouth is opened as wide as possible painlessly at third month; higher scores means a better outcome
Change from baseline maximum mouth opening at 6 months
Time frame: 6. month
the distance between incisal edge of maxillary central incisor to the incisal edge of mandibular central incisor, when the mouth is opened as wide as possible painlessly at 6th month,higher scores means a better outcome
Change from baseline pain at 1 month
Time frame: 1. month
using by Visual Analogue Scale (VAS)
Change from baseline pain at 3 month
Time frame: 3. month
using by Visual Analogue Scale (VAS)
Change from baseline pain at 6 month
Time frame: 6. month
using by Visual Analogue Scale (VAS) higher scores mean worse outcome
1 secondary outcome
Change from baseline 'comfort ' at 6th month
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
Related trials for Temporomandibular Joint Disorders
Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
TMD, Temporomandibular Disorders (TMDs)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder
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.
Genkok center contact
Zeynep B Gonen, DDS,PHD principal investigator
Assoc.Prof
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 Stem Cells in people with Temporomandibular Joint Disorders and Temporomandibular Disorder, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 7 inclusion and 5 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 31 Mar 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 Turkey (Türkiye). 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 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 Zeynep B Gonen, DDS,PHD (00903522076666 ext. 13602, zburcin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Pain at 15th day (time frame: 15th day). The study lists 8 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 31 Mar 2022.