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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTb070230008
Enrollment
22
Registered
2023-04-17
Start date
2023-04-17
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Disease Periodontal Disease

Interventions

Intravenous Administration of Autologous Mesenchymal Stem Cells.
Intravenous Administration, Autologous Mesenchymal Stem Cells

Sponsors

Cho Yasushi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

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

Secondary

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

Countries

Japan

Contacts

Public ContactMichiyo Tokunaga

Medical Corp. Yushikai

fujimoto@hellodc.net+81-96-243-0182

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026