Alveolar bone regeneration therapy using autologous bone marrow stromal cells

Phase 1

• Conditions: Alveolar bone atrophy

• Registration Number: JPRN-UMIN000033847
• Lead Sponsor: Matsumoto Dental University Hospital

Brief Summary

So far, we have recruited 3 patients and cell transplantation was performed to the bone defect sites. Bone biopsy has been performed for 2 patients and dental implants were installed. One of the patients finished the protocol treatment. One of the patients was discontinued due to the circumstances of patient.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-22
• Last Update Posted: 17 October 2023
• Study Completion: 2024-03-08

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

Exclusion Criteria

Patients with diabetes and/or autoimmune diseases, who presented hemorrhagic diathesis where partial thromboplastin time (PT) was lower than 50% and activated partial thromboplastin time (APTT) less than 23.5 or longer than 42.5 seconds, uncontrollable infectious diseases, patients with osteoporosis who are prescribed bisphosphonate, liver dysfunction with a Glutamic Oxaloacetic Transaminase (GOT) value less than 10 or more than 40 IU/L or with a glutamic pyruvic transaminase (GPT) less than 5 or more than 45 IU/L, pregnant or possible pregnancy, allergy to any of the medications used in this study and/or the presence of allergy that required continuous systemic medication, smokers, subjects who are positive for HBs antigen (CLIA), HBs antibody (CLIA), HBc antigen (CLIA), HCV antibody (RIA solid phase), HIV antigen and HIV antibody (ELISAs), syphilis serology (RPR), syphilis serology (TPHA) and HTLV-1 and other special conditions that the responsible physician considered not appropriate were excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone area from biopsy samples: Non-decalcified tissue section from bone biopsy sample will be used and the areas for new bone, remaining beta-TCP, bone marrow, fibrous conective tissue will be analyzed.

Secondary Outcome Measures

Name	Time	Method
Safety: Presence of adverse events during treatment period under the protocol. Newly formed bone volume: CT data will be analyzed and the volume of newly formed bone will be calculated. The hight of bone at the implant installation site will be also analyzed. Osseointegration of Implant. Failure of implant