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Clinical Trials/NCT04340284
NCT04340284CompletedPhase 1

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

Dr. Himanshu Bansal Foundation2 sites in 1 country11 target enrollmentStarted: November 10, 2019Last updated:
Conditions

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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