Bone Neoplasms Clinical Trial
Official title:
Using Mesenchymal Stem Cells to Fill Bone Void Defects in Patients With Benign Bone Lesions
The purpose of this study is to determine whether using mesenchymal stem cells will heal benign bone lesion defects faster than demineralized bone matrix
Orthobiologics have recently become a mainstay in treating bony defects whether related to
trauma, tumor, or other various reconstructive entities.1 Historically, benign bone growths
that were excised, would be filled with either cement, autograft bone, or allograft
substances. More recently, other substances have been utilized. These substances carry any
or all osteoinductive, osteoconductive, or osteogenic properties. Various materials have
been used to fill bony voids specifically related to benign bone growths. Trinity™ by
Blackstone Medical inc. is an allograft substance that has recently began utilization. The
difference in Trinity compared to various other allografts is that it utilizes mesenchymal
stem cells (MSC) along with an allograft carrier to incorporate and induce bone formation.
Previously, in order for stem cells to be included in grafting, it would require bone marrow
aspiration and the morbidity that is associated with iliac crest bone grafting.
Trinity MSC's are pre-immunodepleted and therefore, do not stimulate local T-cell
proliferation but instead are activated to act as osteoblasts and stimulate bone formation.
This local response, could accelerate healing, earlier weight-bearing, healing, and filing
of bone voids in patients that have had excision of bony masses. In previous animal models,
the use of MSC's have been shown to increase bone healing in critical sized defects.
Trinity is currently approved for FDA use in bone defects specifically within the spine or
trauma. It has not been shown to have any significant adverse events over standard bone
substitute products. We hypothesize benign bone lesions that undergo curettage and filling
with Trinity will heal faster than bone lesions filled with basic bone grafting.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02303366 -
Pilot Study of Stereotactic Ablation for Oligometastatic Breast Neoplasia in Combination With the Anti-PD-1 Antibody MK-3475
|
Phase 1 | |
Withdrawn |
NCT00095017 -
Safety and Efficacy of an Investigational Drug Versus Placebo in the Treatment of Cancer Pain (0663-083)
|
Phase 2 | |
Completed |
NCT00168129 -
Helical Tomotherapy as a Radiotherapy Technique for Treating Bone Metastases
|
Phase 1 | |
Completed |
NCT04300179 -
Ewing Sarcoma Family of Tumors (ESFT): A 15-year Experience From a Tertiary Care Cancer Center in Upper Egypt
|
||
Recruiting |
NCT02677961 -
An Electronic Health Record (EHR)-Based Comprehensive Bone and Soft Tissue Tumor Registry
|
||
Completed |
NCT02557243 -
Malignant Pediatric Soft Tissue & Bone Tumors of the Extremities: A Retrospective Study
|
||
Completed |
NCT01479283 -
Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY)
|
Phase 3 | |
Completed |
NCT03839095 -
Localized Osteosarcoma in Upper Egypt: A Clinical Prediction Model
|
||
Recruiting |
NCT06335251 -
Radiotherapy Treatments for Neoplasms of the Limbs
|
||
Completed |
NCT00558272 -
Study to Evaluate the Safety and Effects AZD0530 on Prostate and Breast Cancer Subjects With Metastatic Bone Disease
|
Phase 2 | |
Completed |
NCT00211211 -
FREE Study - Fracture Reduction Evaluation
|
Phase 4 | |
Completed |
NCT02274623 -
Effect of CTAP101 Capsules on Ca/iPTH in Advanced Breast/Prostate Cancer Patients Treated With Denosumab/Zoledronic Acid
|
Phase 1 | |
Completed |
NCT02107664 -
The Palliative Radiotherapy And Inflammation Study - PRAIS
|
||
Terminated |
NCT00381095 -
A Study To Evaluate Pregabalin In The Treatment Of Moderate To Severe Chronic Bone Pain Related To Metastatic Cancer
|
Phase 4 | |
Completed |
NCT00434447 -
Long Term Efficacy and Safety of Zoledronic Acid Treatment in Patients With Bone Metastases
|
Phase 4 | |
Completed |
NCT00909142 -
Bonefos and the Consumption of Analgesics
|
N/A |