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Table 1 The TEOM study data collection schedule

From: Design of a Randomized Controlled Clinical Study of tissue-engineered osteogenic materials using bone marrow-derived mesenchymal cells for Maxillomandibular bone defects in Japan: the TEOM study protocol

 

Screening

Preparation for operation

Operation

Observation period

Registration and assignment

†

Blood sampling

†

Bone marrow sampling

Preoperative examination

Day − 1

Day 0

Day 1

Month 1

Month 3

Month 6

Month 12

Month 24

Eligibility criteria

X

           

Vital signs‡

 

X

 

X

 

X

X

X

    

Laboratory tests

 Infections§, HbA1c

X

           

 Hematology¶, Biochemistry††, CRP, Coagulation‡‡

X

X§§

 

X

  

X

X

X

X

X

X

 Urinalysis¶¶

   

X

  

X

X

X

X

X

X

 Blood sampling

 

X

  

X

       

 Bone marrow sampling

  

X

         

 Panoramic X-ray

X

     

X

X

X

X

X

X

 Facial CT

X

     

X

X

X

X

X

X

 Tooth mobility†††

X

       

X

X

X

X

 Masticatory force

X

      

X

X

X

X

X

 Biopsy of bone (if needed) for histology

       

X

X

X

X

X

 Transplantation of tissue engineered materials

     

X

      

 Concomitant therapies

X

X

X

X

X

X

X

X

X

X

X

X

 Adverse events

 

X

X

X

X

X

X

X

X

X

X

X

  1. † Only BM-MSCs group
  2. ‡ Blood pressure, pulse rate, body temperature
  3. § HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody, serologic test for syphilis, PVB19 antibody
  4. ¶ Red blood cell count, hemoglobin, hematocrit, white blood cell count, fraction of leucocytes (basophil, eosinophil, neutrophil, lymphocyte, monocyte), platelet count
  5. †† Total protein, albumin, total cholesterol, blood urea nitrogen, creatinine, uric acid, sodium, chloride, potassium, calcium, phosphate, lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma-glutamyl transferase, total bilirubin
  6. ‡‡ Prothrombin time, activated partial thromboplastin time, fibrinogen
  7. §§ Only red blood cell count, hemoglobin, white blood cell count, platelet count
  8. ¶¶ pH, protein, glucose, urobilinogen, occult blood
  9. ††† After setting of dental implant
  10. Abbreviations: CRP, C-reactive protein; CT, Computed Tomography