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

NCT04340284 | Completed Phase 1 DMC

• 1 other identifier: HimanshubansalFoundation
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonunion of Fracture

Outcome Measures

Primary Outcomes (1)

• Union

  evidence of union on xray

  8 weeks

Secondary Outcomes (1)

• Short Form 12 survey

  1,2,6,12 months

Study Arms (1)

Patients with nonunion of long bones

EXPERIMENTAL

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)

Interventions

autologous adipose tissue derived stromal vascular fraction (SVF) BIOLOGICAL

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%).

Patients with nonunion of long bones

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-union or delayed union diagnosed after x-ray examination More than 4 cm distance from the joint

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Himanshu Bansal Foundation: lead

Study Sites (1)

Anupam Hospital

Rudrapur, Uttrakhand, 263153, India

Location

Related Publications (4)

• 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.

  PMID: 16557516 RESULT

• 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.

  PMID: 16619257 RESULT

• 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.

  PMID: 27388241 RESULT

• 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.

  PMID: 27538760 RESULT

MeSH Terms

Conditions

Fractures, Ununited

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: April 5, 2020
• First Posted: April 9, 2020
• Study Start: November 10, 2019
• Primary Completion: February 14, 2020
• Study Completion: February 14, 2020
• Last Updated: August 2, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: anytime
• Access Criteria: email TO hbansal@drhbf.org

Locations

IN (1)