Treatment of Nonunion Fractures With Mesenchymal Stromal Cells (MSCs)

NCT06103396 | Unknown Phase 1

• 1 other identifier: IVIC-UTC-MSC-Pseudarthrosis
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pseudoarthrosis of Bone; Pseudarthrosis; Non Union Fracture; Nonunion Bone Fracture

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Autologuos MSCs transplantation in nonunion defects

EXPERIMENTAL

Autologuos MSCs harvested and cultured in osteogenic medium are seeded on collagen scaffold, and mixed with autologous rich plasma clot. The MSCs construct (MSCs/Col/PRP clot), is implanted in the nonunion defect.

Biological: Transplantation of autologous MSCs in nonunion fracture

Allogeneic MSCs transplantation in nonunion defects

EXPERIMENTAL

Allogeneic MSCs harvested and cultured in osteogenic medium are seeded on collagen scaffold, and mixed with autologous rich plasma clot. The MSCs construct (MSCs/Col/PRP clot), is implanted in the nonunion defect.

Biological: Transplantation of allogeneic MSCs in nonunion fracture

Interventions

Transplantation of autologous MSCs in nonunion fracture BIOLOGICAL

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.)

Autologuos MSCs transplantation in nonunion defects

Transplantation of allogeneic MSCs in nonunion fracture BIOLOGICAL

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.)

Allogeneic MSCs transplantation in nonunion defects

Eligibility Criteria

• Age: 10 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Venezolano de Investigaciones Cientificas: lead
• Hospital Central Dr. Plácido D. Rodriguez Rivero: collaborator
• Instituto Autónomo Hospital Universitario de la Universidad de Los Andes: collaborator

Study Sites (1)

Instituto Venezolano de Investigaciones Cientificas

Caracas, Miranda, 1204, Venezuela

Location

Related Publications (3)

• 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.

  PMID: 26980620 BACKGROUND

• 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.

  PMID: 29678307 BACKGROUND

• 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.

  PMID: 26194170 BACKGROUND

MeSH Terms

Conditions

Pseudarthrosis; Fractures, Ununited

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Officials

• Jose E Cardier Montalvo, MD, PhD

  Instituto Venezolano de Investigaciones Cientificas

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 26, 2023
• Study Start: January 30, 2018
• Primary Completion: January 30, 2022
• Study Completion: December 30, 2024
• Last Updated: October 31, 2023

Record last verified: 2023-10

Locations

VE (1)