Abstract

Background Non-union is a common clinical complication that causes serious limb debilities and eventually leads to permanent limb impairments if not treated on time. This proof-of-concept study was undertaken to evaluate the osteogenic potential of autologous adipose derived stromal cells (ADSCs) in long bone non-union.

Methods Seven patients with long-standing atrophic non-union of long bones were treated with percutaneous implantation of a minimum of 100 million ADSC and platelet-rich plasma containing a minimum of 10 billion platelets into the non-union site of long bones under fluoroscopic guidance. Besides radiological imaging for evidence of consolidation, patients were also followed up for clinical parameters, standard lower extremity functional scale (LEFS) and SF12 scores. The patients were followed for a minimum of one year, & Intervention was considered a failure if no evidence of healing was observed up to 6 months post-procedure

Results We observed union in 6 of 7 (86%) patients within 4 months after the procedure. The first evidence of healing was visible within 8 weeks after treatment in five (71%) patients.

Conclusions The study demonstrated the efficacy of ADSCs as a better alternative to bone marrow aspirate concentrate (BMAC) in treating long bone non-union.

Level of Evidence Level 3

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

NCT04340284

Funding Statement

Funding is acknowledged from Anupam Hospital, Uttarakhand, India. (Grant no. 2012/02/ UK/ADM /023)

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

This trial was ethically approved by the Institutional Committee for Stem Cell Research and Therapy, Anupam Hospital, Uttarakhand, India. The trial is compliant with the consolidated standards of reporting trials (CONSORT). Informed prior consent was obtained from all the patients. This trial was registered in Clinicaltrials.gov-NCT04340284; Date of registration 09/04/2020; ClinicalTrial.gov under URL: https://clinicaltrials.gov/ct2/show/NCT04340284).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data produced in the present study are available upon reasonable request to the authors

List of abbreviationsADSCAdipose derived stromal cellBMACBone Marrow Aspirate ConcentrateBM-MSCBone Marrow derived Mesenchymal Stem CellsCFU-FColony-forming-unit fibroblastIMIntramedullaryLEFSLower Extremity Functional ScaleMSCMesenchymal Stem CellsPOPPlaster of pairsPRPPlatelet Rich PlasmaSF-12Short Form 12SVFStromal Vascular Fraction