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Alveolar bone regeneration therapy using autologous bone marrow stromal cells (Alveolar bone regenration using bone marrow stromal cells)

Alveolar bone regeneration therapy using autologous bone marrow stromal cells (Alveolar bone regenration using bone marrow stromal cells)

Yajima Yasutomo

Sept. 29, 2020

3

From 2018, the cell transplantation was performed in 3 cases so far, and dental implants were installed in 2 cases except for 1 case that was discontinued. The superstructures were set, and the follow-up was completed. Due to the spread of Covid-19, the treatment at the outpatient clinic was restricted, and it became difficult to accept new cases. In addition, since the person in charge has left the facility from January 2022, the clinical research was discontinued on December 31, 2021.

From 2018, the cell transplantation was performed in 3 cases so far, and dental implants were installed in 2 cases except for 1 case that was discontinued. The superstructures were set, and the follow-up was completed. Due to the spread of Covid-19, the treatment at the outpatient clinic was restricted, and it became difficult to accept new cases. In addition, since the person in charge has left the facility from January 2022, the clinical research was discontinued on December 31, 2021.

In Case 1, after cell transplantation, rignt maxillary sinusitis occured possibly due to an adjacent dental cyst, but no recurrence was noted until now. There is no adverce events related to the regenerative therapy. In Case 2, no adverse events related to this regenerative therapy have been observed. Case 3 was suffered from Meniere's disease after cell transplantation. No other symptoms or diseases was noted. During 3 years and 3 to 5 months observation period after cell transplantation, no adverse events caused by the tissue-engineered bone grafting was observed in all 3 cases.

ndpoints were evaluated for three sites in two patients. In terms of the primary endpoint, "bone occupancy" of the three samples was 63.1%. The average value of 15 cases by the protocol used hand cultured cells was 45.3%, the bone regeneration capability of the cells with the automated cell culture device was comparable to that of the hand-cultured cells. In terms of "the safety" as a secondary endpoint, there were no diseases or complications related to the regenerative medicine. "Bone volume " were analyzed using CT images and software from 5 to 24 months. The amount of regenerated bone at 24 months was 88.9% compared with that at 6 months. Although the amount of regenerated bone tended to decrease, it was comparable to the result of the same protocol by hand culture (78%). "Implant osseointegration" was obtained in 5 out of 5 (100%), and "loss of implant" did not occur during the follow-up piliod, that was comparable with those in the conventional protocol by hands.

Through the cases, bone tissue engineering by a novel protocol using an automated cell culture device showed the efficacy comparable to that of the conventional protocol by hands, thus it is assumed as an effective method to regenerate alveolar bone.

Dec. 31, 2022

No

At present, there is no plan of sharing IPD data. However, a potential of the secondary use of IPD data and the procedure were described in the research plan and it will be informed to the subject and the consent will be obtained. More specifically, the following contents will be informed to the subjects, i.e. the data collected for this study might be used for other studies in the future, and the contents (although not yet planned or expected in the mean time, but it may become necessary for an important research in the future), the procedures (If the data will be used in the future beyond the scope of the purpose and items explained at the time of partifcipation to this research, the plan should be approved beforehand by the ethics committee of Matsumoto Dental University and the Specific / certified Regenerative Medicine Committee at Tokyo Medical and Dental University), and about the method of providing data to other facilities.

https://jrct.mhlw.go.jp/latest-detail/jRCTb030190222

Kagami Hideaki

Matsumoto Dental University

1780 Hirooka, Gobara, Shiojiri 399-0781, Japan

hideaki.kagami@mdu.ac.jp

Hayakawa Daisuke

Matsumoto Dental University Hospital

1780 Hirooka, Gobara, Shiojiri 399-0781, Japan

+81-263-51-2211

info_byoin@po.mdu.ac.jp

Interventional

single arm study

open(masking not used)

historical control

single assignment

treatment purpose

Subjects were patients who planned to receive dental implant treatment. These subjects had continuous tooth defects (more than 2), where fixed prostheses were not applicable. The subjects voluntarily enrolled in this study and wished to have dental implant treatment rather than conventional removable prostheses. Subjects showed severely atrophic maxilla or mandible, which require bone transplantation. The width of alveolar bone at the installation sites was less than 5 mm. In the maxilla, the distance between the alveolar ridge and the sinus floors was less than 5 mm. Similarly, in the mandible, the distance between the ridge and mandibular canal was less than 5 mm. Good oral hygiene was maintained. Tooth brushing instruction and scaling were performed prior to the protocol treatment. The age of the subjects was limited to 20 -70 years. The subjects were able to understand and agreed to receive the treatment by informed consent.

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.

Both

Alveolar bone atrophy

D019647

transplantation, bone augmentation

Transplantation of tissu-engineered bone

D013515

alveolar bone atrophy, bone defect, dental implant

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.

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

Complete

+81-3-5803-4162

Mar. 10, 2017