Stem Cells and Stromal Vascular Fraction for Temporomandibular Joint Disease

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Stem Cells Transplantation for Temporomandibular Joint Disease: Phase I/II Study

Conditions
-----------------
Temporomandibular Joint Disorders, Temporomandibular Disorder, Temporomandibular Joint Osteoarthritis, Temporomandibular Joint Pain, Temporomandibular Joint Effusion

Intervention / Treatment
-----------------
* Biological: Stem Cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: Cancer patients Immunosupressed patients Previous TMJ traumas and fractures Previous TMJ surgeries TMJ ankylosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: umbilical cord derived mesenchymal stem cells transplantation group<br>taking umbilical cord derived mesenchymal stem cells | Biological: Stem Cells<br>* ATMP<br>|
| Experimental: stromal vascular fraction cells application group<br>taking stromal vascular fraction cells | Biological: Stem Cells<br>* ATMP<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Pain at 15th day | using by Visual Analogue Scale (VAS); higher scores mean worse outcome | 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 | 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 | 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 | 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 | 6. month | 
| Change from baseline pain at 1 month | using by Visual Analogue Scale (VAS) | 1. month | 
| Change from baseline pain at 3 month | using by Visual Analogue Scale (VAS) | 3. month | 
| Change from baseline pain at 6 month | using by Visual Analogue Scale (VAS) higher scores mean worse outcome | 6. month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline 'comfort ' at 6th month | using by Visual Analogue Scale (VAS); higher scores mean better outcome | 6 months |