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

Dr. Himanshu Bansal Foundation

Status and phase: Completed; Phase 2; Phase 1

Conditions: Nonunion of Fracture

Treatments: Biological: autologous adipose tissue derived stromal vascular fraction (SVF)

Study type: Interventional

Funder types: Other

Identifiers

NCT04340284

HimanshubansalFoundation

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Patients with nonunion of long bones

Experimental group

Description:

A total of 11patients ( november 2012 to august 2018) with atrophic non-union of long bones already treated with percutaneous SVF implantation

Treatment:

Biological: autologous adipose tissue derived stromal vascular fraction (SVF)