Autologous Stem Cell Therapy for Fracture Non-union Healing

Not Applicable

Completed

• Conditions: Non-union of Fractures
• Interventions: Biological: carrier plus in vitro expanded autologous BMSCs

• Registration Number: NCT02177565
• Lead Sponsor: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Brief Summary

Do mesenchymal stem cells accelerate new bone formation in persistent non-unions.

Detailed Description

Do mesenchymal stem cells accelerate new bone formation in persistent non-unions treated with carrier plus in vitro expanded autologous BMSCs or carrier alone (control). Secondary aims were to analyze predictors of union in these patients and describe adverse events at final follow-up.

Study Timeline

• Study Start: 2000-01
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2014-06
• Study First Submitted: 2014-06-20
• Study First Submitted QC: 2014-06-25
• Study First Posted: 2014-06-27
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• An established non-union according to the US Food & Drug Administration criteria14.
• Non-union following fracture of tibia or femur suitable for synthetic bone grafting.

Exclusion Criteria

1. Skeletal immaturity.
2. Pregnant or breast-feeding.
3. Non-union following pathological fractures.
4. Positive to Hepatitis B, Hepatitis-C or HIV.
5. Infection during BMSC culture.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
carrier plus BMSCs	carrier plus in vitro expanded autologous BMSCs	carrier plus in vitro expanded autologous BMSCs
carrier alone (control).	carrier plus in vitro expanded autologous BMSCs	Carrier alone

Primary Outcome Measures

Name	Time	Method
Radiological assessment of new callus and fracture bridging	12 months	The primary outcome measure was formation of new callus and cortical bridging, assessed from pre-operative and multiple post-operative radiographs and CT-scans up to 12 months. These images were divided into early (0-3 months) and late (9-12 months) groups. Non-unions were assessed from anonymized slides by four independent reviewers (two radiologists and two orthopedic surgeons) blinded to the side of cell insertion. Each slide had a pre-operative radiograph for comparison but no indication of time since surgery, and showed a medial/ lateral or an anterior/ posterior view depending on the surgical approach . At first, each reviewer indicated the side with largest callus and most cortical bridging pre-operatively. Then each reviewer examined subsequent radiographs to indicate the side with the largest increase in new callus and cortical bridging.

Secondary Outcome Measures

Name	Time	Method
EQ-5D	12 months	Change in EQ-5D index at 1 year was used as secondary outcome measures.

Trial Locations

Locations (1)

Robert Jones & Agnes Hunt Orthopaedic Hospital; 🇬🇧 Oswestry, Shropshire, United Kingdom