NCT04545307: MSC

Transplantation of Allogeneic MSC in Patients With Pulp Necrosis and Chronic Apical Periodontitis

Completed Phase 2, PHASE3 Last updated 16 September 2020

What this trial tests

Phase 2, PHASE3 trial testing Allogenic transplant of BM-MSC in a root canal from patients with immature apexes and pulpar necrosis and apical periodontitis in Pulp Necroses in 5 participants. Completed in 27 January 2020.

Timeline

27 November 2019

Primary endpoint
27 December 2019

27 January 2020

Quick facts

Lead sponsor	Universidad Central de Venezuela
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	27 November 2019
Primary completion	27 December 2019
Estimated completion	27 January 2020
Sites	1 location across Venezuela

Drugs / interventions tested

• Allogenic transplant of BM-MSC in a root canal from patients with immature apexes and pulpar necrosis and apical periodontitis

Conditions studied

• Pulp Necroses — all drugs for Pulp Necroses →
• Apical Periodontitis — all drugs for Apical Periodontitis →

Sponsor

Universidad Central de Venezuela

Who can join

Adults 6 to 16, any sex, with Pulp Necroses or Apical Periodontitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of the study is to evaluate the effect of Mesenchymal Stromal Cell (MSC) implantation on pulp and periapical regeneration of immature teeth with pulp necrosis and chronic apical periodontitis.

BACKGROUND:

* Post-traumatic pulp necrosis prevents root development in children and adolescents.
* The multipotent ability of MSC to differentiate into bone-forming cells (osteoblasts) and dentin-forming cells (Odontoblast) has allowed the development of protocols to induce dental pulp regeneration in preclinical models and patients with immature teeth with pulpal necrosis.

IMPACT:

* Worldwide, post-traumatic pulp necrosis in children and adolescents constitutes a health problem in the endodontic area.
* Treatment with MSC would provide an effective therapeutic alternative to patients with pulp necrosis and incomplete root formation.
* The possible pulp and periapical regeneration of immature teeth induced by MSC would have a huge impact on the treatment of these patients.

Eligibility for EMC implant study Age: 6 to 16 years Sex: Male or Female Healthy volunteers accepted: NO.

TREATMENT GROUPS:

In the present study, the implantation of MSC will be performed in patients with immature teeth with pulpal necrosis with apical periodontitis, who will receive the appropriate endodontic treatment (according to the guidelines of the American Association of Endodontics) and implantation of allogeneic BM-MSC . This group will be compared with the history made in the Postgraduate Endodontics of the Universidad Central de Venezuela (UCV) and with international case series made by revascularization.

Clinical follow-up of each patient:

1. Clinical controls (facial evaluation, gingival evaluation, apical palpation, horizontal and vertical percussion, cold and heat sensitivity tests) will be carried out on days 0, 7, 30, 90, 180 and 364. Additionally, a clinical evaluation will be carried out at the two years post-implantation of MSC.
2. Radiological controls will be carried out on days 0, 7, 30, 90, 180 and 364. Additionally, they will be carried out two years post-implantation of MSC.
3. A tomographic evaluation will be performed when was evident periapical repair in a periapical radiograph. To measure root formation, root canal narrowing and verification the periapical repair in 3D.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mesenchymal Stromal Cells: Heterogeneity and Therapeutical Applications.
   Ouzin M, Kogler G. · · 2023 · cited 22× · PMID 37626848 · DOI 10.3390/cells12162039
2. Wharton's jelly mesenchymal stem cells: Future regenerative medicine for clinical applications in mitigation of radiation injury.
   Sharma P, Maurya DK. · · 2024 · cited 12× · PMID 39086560 · DOI 10.4252/wjsc.v16.i7.742
3. Stem cell-derived exosomes in tissue regeneration of oral and maxillofacial region: A systematic review.
   Dai Q, Dai Q. · · 2026 · PMID 41496030 · DOI 10.1097/md.0000000000046948