Treatment of Nonunion Fractures With Mesenchymal Stromal Cells (MSCs)

Pseudarthrosis Clinical Trial

— MSC  

Official title:

Treatment of Nonunion After Fractures (Pseudoartrosis) Using Mesenchymal Stromal Cells (MSCs)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06103396
• Other study ID #: IVIC-UTC-MSC-Pseudarthrosis
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• Start date: January 30, 2018
• Est. completion date: December 30, 2024

Study information

• Verified date: October 2023
• Source: Instituto Venezolano de Investigaciones Cientificas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to evaluate the bone regeneration capacity of BM-MSC (Bone marrow mesenchymal stromal cells), in patients with nonunion. BM-MSC cultured are seeded on a collagen scaffold, included into autologous platelet-rich plasma (PRP) clot, and implanted in the nonunion bone defect.

Description:

Nonunion (pseudoarthrosis) is one of the most serious complications of bone fracture. Even though different treatments have been used to repair nonunion bone defects, most of them have limitations, like morbidities, limited supply, frequent treatment failure, and high cost. Based on the knowledge that MSC have multipotential capacity of differentiation into bone, cartilage, fat, and endothelial cells, and also, play a key role in the process of bone formation and fracture repair. In this study, we evaluated the use the bone regeneration capacity of autologous or allogeneic BM-MSC, as a potential therapeutic strategy to induce formation of new bone tissue and fracture healing. A bioengineering construct, constituted by MSCs and a collagen scaffold, is incorporated into platelet rich plasma (PRP) clot, wich is implanted at the nonunion site defect.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: December 30, 2024
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 85 Years

Eligibility

Inclusion Criteria:

• Post-traumatic nonunion diagnosis (Pseudoarthrosis) with or without previous ortopaedic treatment
• Patients with or without previous orthopaedic treatment
• Presence of nonunion 9 month or more
• Ossification failure in the non-union area, with an approximate size of 0.5 to 4 cm length

Exclusion Criteria:

• Evidence of infection at the nonunion site (Osteomielitis)
• Evidence of cutaneous lesion at the site of pseudoartrosis
• Viral hepatitis B and C, HIV infection, syphilis and other viral and bacterial infections
• Autoimmune diseases
• Neoplastic diseases
• Pregnancy
• Major metabolic disorders
• Treatment with steroids
• Other conditions or circumstances that compromise the study participation according to medical criteria

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Ununited
• Non Union Fracture
• Pseudarthrosis
• Pseudoarthrosis of Bone

Intervention

Biological:
• Transplantation of autologous MSCs in nonunion fracture
At surgery, fibrotic tissue is removed from the nonunion sites. MSCs/Col/PRP clots are implanted in the site of nonunion. Patients received conventional orthopedic treatment as they needed (osteotomy, external and/or internal fixation systems, etc.)
• Transplantation of allogeneic MSCs in nonunion fracture
At surgery, fibrotic tissue is removed from the nonunion sites. MSCs/Col/PRP clots are implanted in the site of nonunion. Patients received conventional orthopedic treatment as they needed (osteotomy, external and/or internal fixation systems, etc.)

Locations

Country	Name	City	State
Venezuela	Instituto Venezolano de Investigaciones Cientificas	Caracas	Miranda

Sponsors (3)

Lead Sponsor	Collaborator
Instituto Venezolano de Investigaciones Cientificas	Hospital Central Dr. Plácido D. Rodriguez Rivero, Instituto Autónomo Hospital Universitario de la Universidad de Los Andes

Country where clinical trial is conducted

Venezuela, 

References & Publications (3)

Diaz-Solano D, Wittig O, Mota JD, Cardier JE. Isolation and Characterization of Multipotential Mesenchymal Stromal Cells from Congenital Pseudoarthrosis of the Tibia: Case Report. Anat Rec (Hoboken). 2015 Oct;298(10):1804-14. doi: 10.1002/ar.23198. Epub 2015 Jul 30. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical evaluation	Time of surgical wound evolution, surgically intervened limb evolution, movility	Baseline, 1 and 7 days. 1, 2 and 6 months. 1 and 2 years
Primary	Bone consolidation	Time of development changes in bone consolidation by radiological studies	Baseline, 1 and 7 days. 1, 2 and 6 months. 1 and 2 years