Autologous Stem Cell Therapy for Fracture Non-union Healing

Non-union of Fractures Clinical Trial

Official title:

Autologous Stem Cell Therapy for Fracture Non-union Healing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02177565
• Other study ID #: RL1 254
• Secondary ID: Issuing Organisa
• Status: Completed
• Phase: N/A
• Start date: January 2000
• Est. completion date: October 2011

Study information

• Verified date: June 2014
• Source: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 76 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Ununited
• Non-union of Fractures

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Robert Jones & Agnes Hunt Orthopaedic Hospital	Oswestry	Shropshire

Sponsors (2)

Lead Sponsor	Collaborator
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust	Keele University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiological assessment of new callus and fracture bridging	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.	12 months
Secondary	EQ-5D	Change in EQ-5D index at 1 year was used as secondary outcome measures.	12 months