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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Nonunion of Fracture

Intervention / Treatment
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* Biological: autologous adipose tissue derived stromal vascular fraction (SVF)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: retrospective study to report the outcome in patients treated with fluoroscopic guided per cutaneous injection of Adipose tissue derived stromal vascular fraction (SVF) at the site of fracture as an outpatient procedure between November 2012 to August 2018. The indication for this procedure was established atrophic non-union with no evidence of infection with maximum gap between the fragments to be<5 mm and duration not later than one year between the fracture and the procedure. Healing at the injury site was evaluated using clinical and radio logical examination at 1,2,6, and 12 months post-treatment.Anterior-posterior radio graphs
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with nonunion of long bones<br>A total of 11patients ( november 2012 to august 2018) with atrophic non-union of long bones already treated with percutaneous SVF implantation | Biological: autologous adipose tissue derived stromal vascular fraction (SVF)<br>* 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%).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Union | evidence of union on xray | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form 12 survey | 12 item questionnaire used to assess generic health outcomes. scores 0 to 100 with higher the better health | 1,2,6,12 months |