Stem Cells and Stromal Vascular Fraction for Temporomandibular Joint Disease

Temporomandibular Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05305833
• Other study ID #: 2021/584
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2022
• Source: TC Erciyes University
• Contact: Zeynep B Gonen, DDS,PHD
• Phone: 00903522076666
• Email: zburcin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Description:

umbilical cord derived mesenchymal stem cells produced under GMP facility in Erciyes University and SVF produced in operation theatre.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• Disease
• Joint Diseases
• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome
• Temporomandibular Joint Osteoarthritis
• Temporomandibular Joint Pain

Intervention

Biological:
• Stem Cells
ATMP

Locations

Country	Name	City	State
Turkey	Erciyes University	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Pain at 15th day	using by Visual Analogue Scale (VAS); higher scores mean worse outcome	15th day
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Change from baseline pain at 1 month	using by Visual Analogue Scale (VAS)	1. month
Primary	Change from baseline pain at 3 month	using by Visual Analogue Scale (VAS)	3. month
Primary	Change from baseline pain at 6 month	using by Visual Analogue Scale (VAS) higher scores mean worse outcome	6. month
Secondary	Change from baseline 'comfort ' at 6th month	using by Visual Analogue Scale (VAS); higher scores mean better outcome	6 months