Autologous Stem Cell Therapy for Fracture Non-union Healing
Study Details
Study Description
Brief Summary
Do mesenchymal stem cells accelerate new bone formation in persistent non-unions.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: carrier plus BMSCs carrier plus in vitro expanded autologous BMSCs |
Biological: carrier plus in vitro expanded autologous BMSCs
The non-unions of fractures were stabilized with internal or external fixation devices. The non-union site was clearly exposed and decorticated to introduce sub-periosteal bone graft. Depending on the surgical approach, the site was partitioned in either medial/lateral or anterior/posterior sides. The contents of each universal container were mixed individually with a carrier by the surgeon, who was blinded to the contents of the container
|
| Placebo Comparator: carrier alone (control). Carrier alone |
Biological: carrier plus in vitro expanded autologous BMSCs
The non-unions of fractures were stabilized with internal or external fixation devices. The non-union site was clearly exposed and decorticated to introduce sub-periosteal bone graft. Depending on the surgical approach, the site was partitioned in either medial/lateral or anterior/posterior sides. The contents of each universal container were mixed individually with a carrier by the surgeon, who was blinded to the contents of the container
|
Outcome Measures
Primary Outcome Measures
- 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
- EQ-5D [12 months]
Change in EQ-5D index at 1 year was used as secondary outcome measures.
Eligibility Criteria
Criteria
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:
-
Skeletal immaturity.
-
Pregnant or breast-feeding.
-
Non-union following pathological fractures.
-
Positive to Hepatitis B, Hepatitis-C or HIV.
-
Infection during BMSC culture.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Robert Jones & Agnes Hunt Orthopaedic Hospital | Oswestry | Shropshire | United Kingdom | SY10 7AG |
Sponsors and Collaborators
- Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
- Keele University
Investigators
- Principal Investigator: James Richardson, FRCS MD, Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RL1 254
- Issuing Organisation