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Autologous Stem Cell Therapy for Fracture Non-union Healing

Primary Purpose

Non-union of Fractures

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
carrier plus in vitro expanded autologous BMSCs
Sponsored by
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-union of Fractures focused on measuring Non-union, fracture, bone marrow stem cells

Eligibility Criteria

18 Years - 76 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Robert Jones & Agnes Hunt Orthopaedic Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

carrier plus BMSCs

carrier alone (control).

Arm Description

carrier plus in vitro expanded autologous BMSCs

Carrier alone

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

EQ-5D
Change in EQ-5D index at 1 year was used as secondary outcome measures.

Full Information

First Posted
June 20, 2014
Last Updated
March 9, 2020
Sponsor
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Collaborators
Keele University
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1. Study Identification

Unique Protocol Identification Number
NCT02177565
Brief Title
Autologous Stem Cell Therapy for Fracture Non-union Healing
Official Title
Autologous Stem Cell Therapy for Fracture Non-union Healing
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Collaborators
Keele University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-union of Fractures
Keywords
Non-union, fracture, bone marrow stem cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
carrier plus BMSCs
Arm Type
Experimental
Arm Description
carrier plus in vitro expanded autologous BMSCs
Arm Title
carrier alone (control).
Arm Type
Placebo Comparator
Arm Description
Carrier alone
Intervention Type
Biological
Intervention Name(s)
carrier plus in vitro expanded autologous BMSCs
Intervention Description
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
Primary Outcome Measure Information:
Title
Radiological assessment of new callus and fracture bridging
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
EQ-5D
Description
Change in EQ-5D index at 1 year was used as secondary outcome measures.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Richardson, FRCS MD
Organizational Affiliation
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert Jones & Agnes Hunt Orthopaedic Hospital
City
Oswestry
State/Province
Shropshire
ZIP/Postal Code
SY10 7AG
Country
United Kingdom

12. IPD Sharing Statement

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Autologous Stem Cell Therapy for Fracture Non-union Healing

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