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Clinical Study of Safety and Efficacy of Autologous Mesenchymal Stem Cells for Periodontal Tissue Regeneration Therapy

Clinical Study of Safety and Efficacy of Autologous Mesenchymal Stem Cells for Periodontal Tissue Regeneration Therapy

Cho Yasushi

July. 24, 2024

22

The average age of the 22 study participants was 60.1 years, range 41-76 years, comprising 15 men and 7 women. For details, please refer to the summary report.

Regarding the progress of this clinical study, it was newly published on the Clinical Research Submission and Disclosure System (jRCT) on April 17, 2023, and the first subject received the investigational drug on August 31, 2023. Subsequent administrations of the investigational drug continued, and a total of 21 study participants received the drug over the course of one year (April 17, 2023, to April 16, 2024). On April 24, 2024, the investigational drug was administered to the 22nd subject. For details, please refer to the summary report.

Among the 22 subjects who received the investigational drug, there were no cases of adverse events as of the date of submission of this summary report; consequently, there were no cases of disease or other conditions. For details, please refer to the summary report.

In the follow-up assessment conducted three months after treatment, probing depth decreased significantly in 17 of the 21 study participants according to data from both evaluators, indicating an improvement in periodontal symptoms. For details, please refer to the final report.

To evaluate the safety and efficacy of regenerative therapy for periodontal tissues, adipose-derived stem cells were isolated and cultured from adipose tissue harvested from the buccal aspect of the submandibular line or the lower zygomatic region of the study participants, and administered via intravenous infusion to assess safety and efficacy. As a result, no adverse events were observed, probing depths decreased significantly, and improvements in periodontal disease symptoms were noted.

Mar. 31, 2026

Yes

If a dental clinic intends to perform treatments using autologous adipose-derived stem cells for the purpose of treating periodontal disease, it may share the results of this clinical study as an example of prior research.

https://jrct.mhlw.go.jp/latest-detail/jRCTb070230008

Cho Yasushi

Medical Corp. Yushikai

529-1 Shigedomi Ezumachi Higashi-Ward, Kumamoto-City, Kumamoto-Prefecture

fujimoto@hellodc.net

Tokunaga Michiyo

Medical Corp. Yushikai

529-1 Shigedomi Ezumachi Higashi-Ward, Kumamoto-City, Kumamoto-Prefecture

+81-96-243-0182

fujimoto@hellodc.net

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Those who meet all of the following criteria will be considered research subjects for this clinical study.
(1) Those who is more than 20 years and less than 80 years.
(2) Those who have recieved sufficient explanation using ICF and understand the contents, and who have obtained written consent to participate in clinical study based on their free will.
(3) Those who do not show improvement of periodontal symptoms after basic periodontal treatment.
(4) Those who have recieved sufficient explanation about periodontal surgical treatment and understand the details of the treatment, and refuses to undergo periodontal surgical treatment of their own free will.
(5) Those who have periodontal pockets with probing depth of 4 mm or greater on one tooth or multiple contiguous teeth after basic periodontal therapy.
(6) Those who are found to be bleeding after 30 seconds of the probing test.
(7) Those who have more than 1 degree of tooth mobility in one tooth or multiple contiguous teeth.
(8) Those who do not have apical periodontitis or a neoplasm (e.g., malignant tumor) that destroys periodontal tissue.
(9) Those who have the will and ability to visit the clinic until the expiration of the observation period.

Those who meet even one of the following criteria will be excluded from this clinical study.
(1) Those who have experienced hypersensitivity or allergic reactions to anesthetics used during tissue collection or to substances used in the manufacturing process.
(2) Those who has infectious diseases (HIV, HBV, HCV, HTLV-1, Syphilis).
(3) Those who have diabetes mellitus, chronic pain, severe cardiopulmonary disease, thrombosis, brain tumor or cancer of other organs.
(4) Pregnant women, lactating women, and women who may be pregnant.
(5) Other persons deemed inappropriate by dentists.

Both

Periodontal Disease

Intravenous Administration, Autologous Mesenchymal Stem Cells

Intravenous Administration of Autologous Mesenchymal Stem Cells.

D010510

Periodontal Disease

(1) Probing Depth
(2) Presence of Serious Adverse Events

(1) Plaque Adhesion
(2) X-Ray Examination

Complete

+81-3-5615-8311

June. 12, 2023