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Completed

NCT Number: NCT04340284

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

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.

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Key information

Conditions

Nonunion of Fracture Fractures, Bone Fractures, Ununited Wounds and Injuries

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Anupam Hospital

Rudrapur, Uttrakhand, 263153, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

autologous adipose tissue derived stromal vascular fraction (SVF)

Biological

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%).

Primary outcomes

  1. Union

    Time frame: 8 weeks

    evidence of union on xray

Secondary outcomes

  1. Short Form 12 survey

    Time frame: 1,2,6,12 months

    12 item questionnaire used to assess generic health outcomes. scores 0 to 100 with higher the better health

Sponsors and collaborators

Lead sponsor

Dr. Himanshu Bansal Foundation

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 9, 2020
Registry last updated
Aug 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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