Clinical trial NCT05975892: Transplantation of Bone Marrow Mesenchymal Stromal Cells for Periodontal Regeneration
Official title: Transplantation of Bone Marrow Mesenchymal Stromal Cells for Bone Regeneration in Periodontal Disease
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
PHASE2
Conditions: Chronic Periodontal Disease
Aggressive Periodontitis
Keywords: Mesenchymal stromal cells
Periodontal regeneration
Bone regeneration
Periodontitis
Lead sponsor: Instituto Venezolano de Investigaciones Cientificas
Sponsor class: OTHER
Collaborators: name: Universidad Central de Venezuela
name: Hospital Central Dr. Plácido D. Rodriguez Rivero, San Felipe, Yaracuy
First posted: 2023-08-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to evaluate the capacity of allogeneic bone marrow mesenchymal stromal cells (MSC) to induce bone regeneration in patients with periodontal disease. MSC cultured are loaded on a collagen scaffold, included into autologous platelet rich plasma clot and implanted in the bone defect.

Detailed description: The clinical protocol is designed to evaluate the bone regeneration capacity of allogeneic MSCs for the treatment of patients with chronic or aggressive periodontal disease. Patients with either a 2- or 3-wall intrabony defects are included in this study. A bioengineering construct, constituted by allogeneic MSCs and a collagen scaffold, is incorporated into platelet rich plasma (PRP) clot, which is implanted at the bone defect site. Follow up of treated tooth are assessed by clinical evaluation, intraoral radiography and cone-beam CT.

Eligibility criteria: Inclusion Criteria:

* Medical healthy
* Minimum age of 18 years old
* Diagnosis of chronic or aggressive periodontitis
* Vertical intrabony defects of three or two walls
* PPD \>= 5 mm
* Radiographic evidence of alveolar bone loss of at least 3 mm
* Minimim 20 teeth presents in mouth.
* Informed consent of the patient

Exclusion Criteria:

* Smoking
* Pregnancy or lactating
* Receiving immunosuppressive drugs, anticoagulants, antibiotics or analgesic drugs
* Diabetics

Primary outcomes:
measure: Change in clinical attachment level (CAL)
timeFrame: Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation
measure: Change in probing pocket depth (PPD)
timeFrame: Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation
measure: Gingival recession (GR)
timeFrame: Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation
measure: Change in bone density
timeFrame: Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation
measure: Change in Tooth Mobility (TM)
timeFrame: Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation
measure: Change in bone depth
timeFrame: Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Caracas
country: Venezuela
facility: Instituto Venezolano de Investigaciones Cientificas
state: Miranda
Study officials:
affiliation: Instituto Venezolano de Investigaciones Cientificas
name: Jose E Cardier Montalvo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wittig O, Diaz-Solano D, Cardier J. Viability and functionality of mesenchymal stromal cells loaded on collagen microspheres and incorporated into plasma clots for orthopaedic application: Effect of storage conditions. Injury. 2018 Jun;49(6):1052-1057. doi: 10.1016/j.injury.2018.04.005. Epub 2018 Apr 5.
citation: Wittig O, Romano E, Gonzalez C, Diaz-Solano D, Marquez ME, Tovar P, Aoun R, Cardier JE. A method of treatment for nonunion after fractures using mesenchymal stromal cells loaded on collagen microspheres and incorporated into platelet-rich plasma clots. Int Orthop. 2016 May;40(5):1033-8. doi: 10.1007/s00264-016-3130-6. Epub 2016 Mar 16.
citation: Gomez M, Wittig O, Diaz-Solano D, Cardier JE. Mesenchymal Stromal Cell Transplantation Induces Regeneration of Large and Full-Thickness Cartilage Defect of the Temporomandibular Joint. Cartilage. 2021 Dec;13(1_suppl):1814S-1821S. doi: 10.1177/1947603520926711. Epub 2020 Jun 4.
citation: Gomez-Sosa JF, Diaz-Solano D, Wittig O, Cardier JE. Dental Pulp Regeneration Induced by Allogenic Mesenchymal Stromal Cell Transplantation in a Mature Tooth: A Case Report. J Endod. 2022 Jun;48(6):736-740. doi: 10.1016/j.joen.2022.03.002. Epub 2022 Mar 18.