Adipose Tissue Derived Stromal Vascular Fraction (SVF) Application in Treatment of Long Bones Nonunion
Primary Purpose
Nonunion of Fracture
Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
autologous adipose tissue derived stromal vascular fraction (SVF)
Sponsored by
About this trial
This is an interventional treatment trial for Nonunion of Fracture
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
Sites / Locations
- Anupam Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with nonunion of long bones
Arm Description
A total of 11patients ( november 2012 to august 2018) with atrophic non-union of long bones already treated with percutaneous SVF implantation
Outcomes
Primary Outcome Measures
Union
evidence of union on xray
Secondary Outcome Measures
Short Form 12 survey
12 item questionnaire used to assess generic health outcomes. scores 0 to 100 with higher the better health
Full Information
NCT ID
NCT04340284
First Posted
April 5, 2020
Last Updated
July 30, 2022
Sponsor
Dr. Himanshu Bansal Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04340284
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 10, 2019 (Actual)
Primary Completion Date
February 14, 2020 (Actual)
Study Completion Date
February 14, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Himanshu Bansal Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonunion of Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with nonunion of long bones
Arm Type
Experimental
Arm Description
A total of 11patients ( november 2012 to august 2018) with atrophic non-union of long bones already treated with percutaneous SVF implantation
Intervention Type
Biological
Intervention Name(s)
autologous adipose tissue derived stromal vascular fraction (SVF)
Intervention Description
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 Outcome Measure Information:
Title
Union
Description
evidence of union on xray
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Short Form 12 survey
Description
12 item questionnaire used to assess generic health outcomes. scores 0 to 100 with higher the better health
Time Frame
1,2,6,12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Anupam Hospital
City
Rudrapur
State/Province
Uttrakhand
ZIP/Postal Code
263153
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
any information needed will be gladly shared
IPD Sharing Time Frame
anytime
IPD Sharing Access Criteria
email TO hbansal@drhbf.org
IPD Sharing URL
http://www.drhbf.org
Citations:
PubMed Identifier
16557516
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.
Results Reference
result
PubMed Identifier
16619257
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.
Results Reference
result
PubMed Identifier
27388241
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.
Results Reference
result
PubMed Identifier
27538760
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.
Results Reference
result
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Adipose Tissue Derived Stromal Vascular Fraction (SVF) Application in Treatment of Long Bones Nonunion
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