NCT04340284

Adipose Tissue Derived Stromal Vascular Fraction (SVF) Application in Treatment of Long Bones Nonunion

Retrospective Study to Analyze Safety and Efficacy of Adipose Tissue Derived Stromal Vascular Fraction (SVF) Application in Treatment of Long Bones Nonunion

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Dr. Himanshu Bansal Foundation · Academic / Other
• Sex: All
• Age: 25 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Nonunion is a major complication of fractures.Per cutaneous bone marrow concentrate (BMC) application around fracture ends is being utilized with great success . Mesenchymal Stem Cells (MSCs)are one of the major cell types found in BMC responsible for results Adipose tissue is an alternative source for MSCs. Besides abundant and readily accessible it also overcomes issue of morbidity with bone marrow aspiration. this retrospective analysis to report the outcome in patients treated with fluoroscopic guided percutaneous injection of SVF at the site of fracture as an outpatient procedure between November 2012 to August 2018.

Detailed description

Nonunion is of major complication of fractures .The overall rate of non-union is still not clear but estimates from the published literature suggests a range between 5-10% of the total fractures.The gap in non-healing management has instigated the search for novel osteo-inductive substances. bone marrow concentrate is being utilized for many year with excellent results .Mesenchymal Stem Cells (MSCs)are one of the major cell types of the Bone Marrow Aspirate Concentrate (BMAC)that self-renovates and differentiates into multiple cell types of mesodermal origin such as osteoblasts, chondrocytes, and adipocytes. Adipose tissue is an alternative source for MSCs .besides abundant and readily accessible it also overcomes issue of morbidity with bone marrow aspiration. This retrospective analysis was conducted to report the outcome in patients treated with fluoroscopic guided percutaneous injection of SVF at the site of fracture as an outpatient procedure between November 2012 to August 2018. The purpose of this study is to report the feasibility of minimally invasive percutaneous injection with autologous SVF and study the osteo-inductive efficacy of Adipose derived stromal cells in SVF in the management of non-union.

Conditions

• Nonunion of Fracture

Interventions

Type	Name	Description
BIOLOGICAL	autologous adipose tissue derived stromal vascular fraction (SVF)	liquid and solid portion of lipo-aspirate after non enzymatic processing yields SVF. This isolation process yielded an abundant population of Adipose stromal cells(ASCs) which have multipotent differentiation potential. Immunophenotype is a CD14-, CD29+, CD31-, CD34low/+, CD45-, CD73+ and CD105+ , , the SVF represents the 50-70% in volume of a lipoaspirate specimen. The SVF hosts a heterogeneous cell population (110x103 cells/ml on average) comprising mainly CD105+ mesenchymal stem cells (MSC, 20%), plus a wide number of CD34+ hematopoietic cells (40%).

Timeline

• Start date: 2019-11-10
• Primary completion: 2020-02-14
• Completion: 2020-02-14
• First posted: 2020-04-09
• Last updated: 2022-08-02

Locations

1 site across 1 country: India