A Phase 1/2 interventional study of Transplantation of autologous MSCs in nonunion fracture and Transplantation of allogeneic MSCs in nonunion fracture in Pseudoarthrosis of Bone, Pseudarthrosis and Non Union Fracture, sponsored by Instituto Venezolano de Investigaciones Cientificas. Enrolling by invitation at 1 site in Venezuela. Open to participants aged 10 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-10-31.
Sponsored by Instituto Venezolano de Investigaciones Cientificas · Phase 1/2, Interventional, and Treatment
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.
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.
41 studies on the registry are indexed under Pseudarthrosis; 7 are open to participants now.
This study's planned enrollment of 30 is above the median of 22 across 25 interventional studies indexed under Pseudarthrosis.
Browse Pseudarthrosis studies →Instituto Venezolano de Investigaciones Cientificas is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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
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.)
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.)
Clinical evaluation
Time of surgical wound evolution, surgically intervened limb evolution, movility
Time frame: 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
Time frame: Baseline, 1 and 7 days. 1, 2 and 6 months. 1 and 2 years
Ran from Jan 2018 to primary completion in Jan 2022, 48 months.
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Instituto Venezolano de Investigaciones Cientificas