Clinical trial NCT04340284: Adipose Tissue Derived Stromal Vascular Fraction (SVF) Application in Treatment of Long Bones Nonunion
Official title: Retrospective Study to Analyze Safety and Efficacy of Adipose Tissue Derived Stromal Vascular Fraction (SVF) Application in Treatment of Long Bones Nonunion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Nonunion of Fracture
Lead sponsor: Dr. Himanshu Bansal Foundation
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 11
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Union
timeFrame: 8 weeks
Secondary outcomes:
measure: Short Form 12 survey
timeFrame: 1,2,6,12 months
Other outcomes:
Locations:
city: Rudrapur
country: India
facility: Anupam Hospital
state: Uttrakhand
Study officials:
References:
citation: Yoshimura K, Shigeura T, Matsumoto D, Sato T, Takaki Y, Aiba-Kojima E, Sato K, Inoue K, Nagase T, Koshima I, Gonda K. Characterization of freshly isolated and cultured cells derived from the fatty and fluid portions of liposuction aspirates. J Cell Physiol. 2006 Jul;208(1):64-76. doi: 10.1002/jcp.20636.
citation: Caplan AI, Dennis JE. Mesenchymal stem cells as trophic mediators. J Cell Biochem. 2006 Aug 1;98(5):1076-84. doi: 10.1002/jcb.20886.
citation: Prins HJ, Schulten EA, Ten Bruggenkate CM, Klein-Nulend J, Helder MN. Bone Regeneration Using the Freshly Isolated Autologous Stromal Vascular Fraction of Adipose Tissue in Combination With Calcium Phosphate Ceramics. Stem Cells Transl Med. 2016 Oct;5(10):1362-1374. doi: 10.5966/sctm.2015-0369. Epub 2016 Jul 7.
citation: Saxer F, Scherberich A, Todorov A, Studer P, Miot S, Schreiner S, Guven S, Tchang LA, Haug M, Heberer M, Schaefer DJ, Rikli D, Martin I, Jakob M. Implantation of Stromal Vascular Fraction Progenitors at Bone Fracture Sites: From a Rat Model to a First-in-Man Study. Stem Cells. 2016 Dec;34(12):2956-2966. doi: 10.1002/stem.2478. Epub 2016 Sep 16.