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Stem Cells and Stromal Vascular Fraction for Temporomandibular Joint Disease

Primary Purpose

Temporomandibular Joint Disorders, Temporomandibular Disorder, Temporomandibular Joint Osteoarthritis

Status
Recruiting
Phase
Phase 1
Locations
Turkey
Study Type
Interventional
Intervention
Stem Cells
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Erciyes UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

umbilical cord derived mesenchymal stem cells transplantation group

stromal vascular fraction cells application group

Arm Description

taking umbilical cord derived mesenchymal stem cells

taking stromal vascular fraction cells

Outcomes

Primary Outcome Measures

Change from Baseline Pain at 15th day
using by Visual Analogue Scale (VAS); higher scores mean worse outcome
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
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
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
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
Change from baseline pain at 1 month
using by Visual Analogue Scale (VAS)
Change from baseline pain at 3 month
using by Visual Analogue Scale (VAS)
Change from baseline pain at 6 month
using by Visual Analogue Scale (VAS) higher scores mean worse outcome

Secondary Outcome Measures

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

Full Information

First Posted
November 12, 2021
Last Updated
March 23, 2022
Sponsor
TC Erciyes University
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1. Study Identification

Unique Protocol Identification Number
NCT05305833
Brief Title
Stem Cells and Stromal Vascular Fraction for Temporomandibular Joint Disease
Official Title
Stem Cells Transplantation for Temporomandibular Joint Disease: Phase I/II Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders, Temporomandibular Disorder, Temporomandibular Joint Osteoarthritis, Temporomandibular Joint Pain, Temporomandibular Joint Effusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
umbilical cord derived mesenchymal stem cells transplantation group
Arm Type
Experimental
Arm Description
taking umbilical cord derived mesenchymal stem cells
Arm Title
stromal vascular fraction cells application group
Arm Type
Experimental
Arm Description
taking stromal vascular fraction cells
Intervention Type
Biological
Intervention Name(s)
Stem Cells
Intervention Description
ATMP
Primary Outcome Measure Information:
Title
Change from Baseline Pain at 15th day
Description
using by Visual Analogue Scale (VAS); higher scores mean worse outcome
Time Frame
15th day
Title
Change from baseline maximum mouth opening at 15th day
Description
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
Time Frame
15th day
Title
Change from baseline maximum mouth opening at 1 month
Description
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
Time Frame
1. month
Title
Change from baseline maximum mouth opening at 3 months
Description
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
Time Frame
3. month
Title
Change from baseline maximum mouth opening at 6 months
Description
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
Time Frame
6. month
Title
Change from baseline pain at 1 month
Description
using by Visual Analogue Scale (VAS)
Time Frame
1. month
Title
Change from baseline pain at 3 month
Description
using by Visual Analogue Scale (VAS)
Time Frame
3. month
Title
Change from baseline pain at 6 month
Description
using by Visual Analogue Scale (VAS) higher scores mean worse outcome
Time Frame
6. month
Secondary Outcome Measure Information:
Title
Change from baseline 'comfort ' at 6th month
Description
using by Visual Analogue Scale (VAS); higher scores mean better outcome
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zeynep B Gonen, DDS,PHD
Phone
00903522076666
Ext
13602
Email
zburcin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Genkok center
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeynep B Gonen, DDS,PHD
Organizational Affiliation
Assoc.Prof
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erciyes University
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Genkok Center
Phone
00903522076666
Ext
13600
First Name & Middle Initial & Last Name & Degree
ALPER KEMALOGLU, MD
First Name & Middle Initial & Last Name & Degree
IRFAN OZYAZGAN, MD
First Name & Middle Initial & Last Name & Degree
GOKCEN DINC, PHD

12. IPD Sharing Statement

Learn more about this trial

Stem Cells and Stromal Vascular Fraction for Temporomandibular Joint Disease

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