Autologous Stem Cell Therapy for Fracture Non-union Healing
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 35
- Locations
- 2
- Primary Endpoint
- Radiological assessment of new callus and fracture bridging
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 76 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •An established non-union according to the US Food & Drug Administration criteria
- •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.
Outcomes
Primary Outcomes
Radiological assessment of new callus and fracture bridging
Time Frame: 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 Outcomes
- EQ-5D(12 months)