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

Phase 1

Completed

• Conditions: Nonunion of Fracture
• Interventions: Biological: autologous adipose tissue derived stromal vascular fraction (SVF)

• Registration Number: NCT04340284
• Lead Sponsor: Dr. Himanshu Bansal Foundation

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 Timeline

• Study Start: 2019-11-10
• Primary Completion: 2020-02-14
• Study Completion: 2020-02-14
• Study First Submitted: 2020-04-05
• Study First Submitted QC: 2020-04-08
• Study First Posted: 2020-04-09
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-30
• Last Update Posted: 2022-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with nonunion of long bones	autologous adipose tissue derived stromal vascular fraction (SVF)	A total of 11patients ( november 2012 to august 2018) with atrophic non-union of long bones already treated with percutaneous SVF implantation

Primary Outcome Measures

Name	Time	Method
Union	8 weeks	evidence of union on xray

Secondary Outcome Measures

Name	Time	Method
Short Form 12 survey	1,2,6,12 months	12 item questionnaire used to assess generic health outcomes. scores 0 to 100 with higher the better health

Trial Locations

Locations (1)

Anupam Hospital; 🇮🇳 Rudrapur, Uttrakhand, India