Stem Cells and Stromal Vascular Fraction for Temporomandibular Joint Disease

Phase 1

• Conditions: Temporomandibular Joint Osteoarthritis; Temporomandibular Disorder; Temporomandibular Joint Pain; Temporomandibular Joint Disorders; Temporomandibular Joint Effusion
• Interventions: Biological: Stem Cells

• Registration Number: NCT05305833
• Lead Sponsor: TC Erciyes University

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.

Study Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2021-11-12
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-23
• Last Update Submitted: 2022-03-23
• Study First Posted: 2022-03-31
• Last Update Posted: 2022-03-31
• Primary Completion: 2022-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
umbilical cord derived mesenchymal stem cells transplantation group	Stem Cells	taking umbilical cord derived mesenchymal stem cells
stromal vascular fraction cells application group	Stem Cells	taking stromal vascular fraction cells

Primary Outcome Measures

Name	Time	Method
Change from baseline maximum mouth opening at 3 months	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 15th day	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	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 pain at 3 month	3. month	using by Visual Analogue Scale (VAS)
Change from baseline pain at 6 month	6. month	using by Visual Analogue Scale (VAS) higher scores mean worse outcome
Change from Baseline Pain at 15th day	15th day	using by Visual Analogue Scale (VAS); higher scores mean worse outcome
Change from baseline maximum mouth opening at 6 months	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	1. month	using by Visual Analogue Scale (VAS)

Secondary Outcome Measures

Name	Time	Method
Change from baseline 'comfort ' at 6th month	6 months	using by Visual Analogue Scale (VAS); higher scores mean better outcome

Trial Locations

Locations (1)

Erciyes University; 🇹🇷 Kayseri, Turkey