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

Sponsor

Dr. Himanshu Bansal Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT04340284

Collaborator

(none)

Enrollment

Location

Arm

3.2

Actual Duration (Months)

3.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Nonunion of Fracture	Biological: autologous adipose tissue derived stromal vascular fraction (SVF)	Phase 1/Phase 2

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

Actual Enrollment :

11 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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 graphsretrospective 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)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 10, 2019

Actual Primary Completion Date :

Feb 14, 2020

Actual Study Completion Date :

Feb 14, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients with nonunion of long bones A total of 11patients ( november 2012 to august 2018) with atrophic non-union of long bones already treated with percutaneous SVF implantation	Biological: autologous adipose tissue derived stromal vascular fraction (SVF) 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%).

Arm

Intervention/Treatment

Experimental: Patients with nonunion of long bones

A total of 11patients ( november 2012 to august 2018) with atrophic non-union of long bones already treated with percutaneous SVF implantation

Biological: autologous adipose tissue derived stromal vascular fraction (SVF)

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%).

Outcome Measures

Primary Outcome Measures

Union [8 weeks]
evidence of union on xray

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anupam Hospital	Rudrapur	Uttrakhand	India	263153

Sponsors and Collaborators

Dr. Himanshu Bansal Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Himanshu Bansal Foundation

ClinicalTrials.gov Identifier:

NCT04340284

Other Study ID Numbers:

HimanshubansalFoundation

First Posted:

Apr 9, 2020

Last Update Posted:

Aug 2, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fractures, Ununited

Study Results

No Results Posted as of Aug 2, 2022