A phase I/IIa safety and efficacy study of allogeneic periodontal ligament-derived mesenchymal stromal cell sheet product (TWP-0001) in patients with periodontitis, consisting of 1 wall intrabony defect, Class III furcation defect, or horizontal defect, with probing depths of 4 - 9 mm after the initial therapy

A phase I/IIa safety and efficacy study of allogeneic periodontal ligament-derived mesenchymal stromal cell sheet product (TWP-0001) in patients with periodontitis, consisting of 1 wall intrabony defect, Class III furcation defect, or horizontal defect, with probing depths of 4 - 9 mm after the initial therapy - Periodontal regeneration by allogeneic periodontal ligament-derived mesenchymal stromal cell sheets

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000034310

Enrollment

Registered

2018-09-28

Start date

2018-11-05

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

Periodontitis, consisting of 1 wall intrabony defect, Class III furcation defect, or horizontal defect, with probing depths of 4 - 9 mm after the initial therapy

Interventions

Allogeneic periodontal ligament-derived mesenchymal stromal cell sheet product (TWP-0001) Single transplantation adjust to the defect size

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Periodontitis, consisting of 1 wall intrabony defect, Class III furcation defect, or horizontal defect, with probing depths of 4 - 9 mm after the initial therapy

Exclusion criteria

Exclusion criteria: maxillary Class III furcation

Design outcomes

Primary

Measure	Time frame
Safety 1) Adverse event 2) Pain scoring by interview and observation 3) Blood tests and urinary tests	—

Secondary

Measure	Time frame
Efficacy 1) Linear bone gain at 26 and 36 weeks after the transplantation. 2) Gain of clinical attachment level 3) Changes of periodontal examinations	—

Countries

Japan

Contacts

Public ContactTakanori Iwata

Tokyo Medical and Dental University Graduate School, Department of Periodontology

iwata.peri@tmd.ac.jp0358035488

Outcome results

None listed

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