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Stem Cells and Stromal Vascular Fraction for Temporomandibular Joint Disease

T

TC Erciyes University

Status and phase

Unknown
Phase 2
Phase 1

Conditions

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

Treatments

Biological: Stem Cells

Study type

Interventional

Funder types

Other

Identifiers

NCT05305833
2021/584

Details and patient eligibility

About

It will be evaluate the safety of mesenchymal stem cells and adipose tissue derived stromal vascular fraction (SVF) in temporomandibular joint disease cases.

Full description

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

Enrollment

20 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

20 participants in 2 patient groups

umbilical cord derived mesenchymal stem cells transplantation group
Experimental group
Description:
taking umbilical cord derived mesenchymal stem cells
Treatment:
Biological: Stem Cells
stromal vascular fraction cells application group
Experimental group
Description:
taking stromal vascular fraction cells
Treatment:
Biological: Stem Cells

Trial contacts and locations

1

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Central trial contact

Genkok center; Zeynep B Gonen, DDS,PHD

Data sourced from clinicaltrials.gov

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