A clinical study for validity and provision method of periodontal tissue regeneration with autologous adipose derived stem cells and platelet rich plasma

JRCT ID: jRCTb030190173

Registered date:06/01/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: periodontitis
• Date of first enrollment: 20/06/2019
• Target sample size: 15
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Subcutaneous adipose tissue and blood collection, administration of cell processing products

Outcome(s)

• Primary Outcome: efficacy
• Secondary Outcome: Safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Have a Periodontal pocket more than 5 mm at baseline examination.
2. Intrabony defect is 5 mm and more depth, and 2 mm and more width at interproximal site of the experimental tooth by X-ray examination.
3. Already have received initial preparation at the screening.
4. Mobility of experimental tooth is 0, 1, or 2, and exist keratinized gingiva.
5. Good oral health.
6. Subcutaneous fat tissue can be harvest normally and safely
7. 20 years and older.
8. Signed informed consent.

Exclude criteria

1. Can not be measured clinical attachment level of experimental tooth.
2. Have a history of Complicate malignant tumor.
3. Suspected of oral malignant tumor or precancerous lesion.
4. Need to undergo the treatment, such as surgical treatment, restorative treatment or root canal treatment, at the experimental tooth within 36 weeks after transplant.
5. Pregnancy, during breastfeeding, or possibility of pregnancy.
6. Have serious cardiac diseases.
7. Have serious liver diseases.
8. Have end-stage renal diseases or on hemodialysis.
9. Serious coagulopathies.
10. Hemoglobin A1c is more than 6.8% at the screening.
11. Have active infectious diseases.
12. Alcoholism or Drug dependence.
13. Mental or consciousness disorder.
14. HCV antibody, HBs antigen, ATLA virus antibody or HIV antibody positive person.
15. Smoke more than 10 pieces per day.
16. Other, the investigator believes makes him/her unsuitable for participation in the clinical study.

Related Information

• Primary Sponsor: Tobita Morikuni
• Source(s) of Monetary Support: Japan agency of medical research and development