Periodontal tissue regeneration therapy using an autologous adipose tissue-derived multi-lineage progenitor cells

JRCT ID: jRCTb050240049

Registered date:01/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: severe periodotitis
• Date of first enrollment: 01/06/2024
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): After culturing and collecting adipose tissue-derived multilineage progenitor cells (ADMPCs) from the autologous adipose tissue, the person in charge of implementation or the dentist who performs regenerative medicine transplant the cells. After making a gingival sulcus incision and leaving the interdental papilla as much as possible, the gingival periosteal valve is inverted with a full-thickness valve to perform scaling and root planing. The curette uses a Gracie type scaler. ADMPCs are mixed with a carbonated apatite preparation and filled with a spartel according to the morphology of the affected alveolar bone defect.

Outcome(s)

• Primary Outcome: Clinical attachment level acquired 36 weeks after transplantation and its change over time

Secondary Outcome

1) Increase rate of new alveolar bone 36 weeks after transplantation and its change over time
2) Volume of new alveolar bone 36 weeks after transplantation
3) Changes in periodontal tissue test values over time

Key inclusion & exclusion criteria

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

Include criteria

1) Patients over 20 years old at the time of consent acquisition.
2) Patients with test teeth that meet all of the following criteria.
1. Teeth diagnosed with severe periodontitis (teeth meet at least one of the following criteria, 33% or more alveolar bone resorption, 5mm or more clinical attachment loss , 6mm or more probing pocket depth) at the initial visit.
2. Teeth with vertical bone defects of 2mm or more in width on its mesial or distal site (excluding three-wall bone defects), or with one- or four-wall bone defects less than 4mm depth and less than 2mm wide.
3. Teeth with tooth mobility of 2 degree or less, and with keratinized gingiva that are judged to be capable of flap operation.
3) Patients who have received the initial periodontal therapy.
4) Patients whose oral hygiene is established, are determined to be able to maintain good oral hygiene under the guidance of dentists after the treatment of regenerative medicine.
5) Patients who have written consent to participate in this clinical study.

Exclude criteria

1) Patients who have a prosthesis that interferes with the accurate measurement of the clinical attachment level of the test site.
2) Patients with or have a history of malignant tumors.
3) Patients with malignant tumors, precancerous lesions or suspected findings in the oral cavity in the oral diagnosis before registration.
4) Patients who have used or will use drugs that carry a risk of osteonecrosis of the alveolar bone.
5) Patients who need to undergo treatment that affects the evaluation of the test site within 36 weeks after stem cell transplantation.
6) Patients who are pregnant, breastfeeding, wish to become pregnant by 36 weeks after transplantation, or may be pregnant (determined by pre-registration pregnancy test).
7) Patients with severe blood disorders or bone-targeted hormone metabolic disorders.
8) Patients with abnormalities in calcium metabolism organs such as kidneys and digestive organs or suspected connective tissue disease.
9) Patients undergoing dialysis or receiving steroids.
10) Patients with unmanageable comorbidities that limit compliance with clinical research requirements.
11) Patients with hemoglobin A1c of 6.5% or higher in pre-registration laboratory tests.
12) Patients with a history of alcoholism or drug addiction.
13) Patients who are positive for HCV antibody, HBs antigen, ATLA antibody, and HIV antibody.
14) Patients who are considered inappropriate to participate in this clinical study at the discretion of the person in charge of implementation.

Related Information

• Primary Sponsor: Takedachi Masahide
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development