Stem Cells and Stromal Vascular Fraction for Temporomandibular Joint Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Temporomandibular Joint Disorders; Temporomandibular Disorder; Temporomandibular Joint Pain; Temporomandibular Joint Osteoarthritis; Temporomandibular Joint Effusion
• Intervention / Treatment: Biological: Stem Cells

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Zeynep B Gonen, DDS,PHD; Phone Number: 13602 00903522076666; Email: zburcin@gmail.com
• Study Contact Backup: Name: Genkok center

Study Locations

• Turkey
  • Kayseri, Turkey, 38039
    • Recruiting
    • Erciyes University
    • Contact: Genkok Center; Phone Number: 13600 00903522076666
    • Sub-Investigator: ALPER KEMALOGLU, MD
    • Sub-Investigator: IRFAN OZYAZGAN, MD
    • Sub-Investigator: GOKCEN DINC, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: umbilical cord derived mesenchymal stem cells transplantation group; taking umbilical cord derived mesenchymal stem cells	Biological: Stem Cells; ATMP
Experimental: stromal vascular fraction cells application group; taking stromal vascular fraction cells	Biological: Stem Cells; ATMP

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

Collaborators and Investigators

• Sponsor: TC Erciyes University
• Investigators: Principal Investigator: Zeynep B Gonen, DDS,PHD, Assoc.Prof

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: November 12, 2021
• First Submitted That Met QC Criteria: March 23, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 23, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Arthralgia; Disease; Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: 2021/584

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No