Clinical trial NCT06103396: Treatment of Nonunion Fractures With Mesenchymal Stromal Cells (MSCs)
Official title: Treatment of Nonunion After Fractures (Pseudoartrosis) Using Mesenchymal Stromal Cells (MSCs)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
PHASE2
Conditions: Pseudoarthrosis of Bone
Pseudarthrosis
Non Union Fracture
Nonunion Bone Fracture
Lead sponsor: Instituto Venezolano de Investigaciones Cientificas
Sponsor class: OTHER
Collaborators: name: Hospital Central Dr. Plácido D. Rodriguez Rivero
name: Instituto Autónomo Hospital Universitario de la Universidad de Los Andes
First posted: 2023-10-26
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical evaluation
timeFrame: Baseline, 1 and 7 days. 1, 2 and 6 months. 1 and 2 years
measure: Bone consolidation
timeFrame: Baseline, 1 and 7 days. 1, 2 and 6 months. 1 and 2 years
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: STUDY_CHAIR
References:
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: 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: 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.