Retrospective Study to Analyze Safety and Efficacy of Adipose Tissue Derived Stromal Vascular Fraction (SVF) Application in Treatment of Long Bones Nonunion
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 11
- Locations
- 2
- Primary Endpoint
- Union
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Non-union or delayed union diagnosed after x-ray examination More than 4 cm distance from the joint
Exclusion Criteria
- •Multiple major fracture or untreated major fracture
- •Infected fracture
- •HIV, hepatitis B or hepatitis C infection at the time of screening
- •Diagnosis of cancer
- •Active treatment with immunosuppressive drugs or anticoagulant agents
- •Known allergic reaction to components of study treatment and/or study injection
Outcomes
Primary Outcomes
Union
Time Frame: 8 weeks
evidence of union on xray
Secondary Outcomes
- Short Form 12 survey(1,2,6,12 months)