Stem Cells and Stromal Vascular Fraction for Temporomandibular Joint Disease

NCT ID: NCT05305833

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2023-12-01

Brief Summary

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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

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

Conditions

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Temporomandibular Joint Disorders Temporomandibular Disorder Temporomandibular Joint Osteoarthritis Temporomandibular Joint Pain Temporomandibular Joint Effusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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umbilical cord derived mesenchymal stem cells transplantation group

taking umbilical cord derived mesenchymal stem cells

Group Type EXPERIMENTAL

Stem Cells

Intervention Type BIOLOGICAL

ATMP

stromal vascular fraction cells application group

taking stromal vascular fraction cells

Group Type EXPERIMENTAL

Stem Cells

Intervention Type BIOLOGICAL

ATMP

Interventions

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Stem Cells

ATMP

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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Zeynep Burcin GONEN

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zeynep B Gonen, DDS,PHD

Role: PRINCIPAL_INVESTIGATOR

Assoc.Prof

Locations

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Erciyes University

Kayseri, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Zeynep B Gonen, DDS,PHD

Role: CONTACT

Phone: 00903522076666

Email: [email protected]

Genkok center

Role: CONTACT

Facility Contacts

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Genkok Center

Role: primary

Other Identifiers

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2021/584

Identifier Type: -

Identifier Source: org_study_id