Trial intelligence / Profile preview

TRC Autologous Bone Marrow Cells in Posterolateral Lumbar Spine Fusion

NCT00797550Phase 2

Key facts

Status: Terminated
Start: Apr 2006
Primary completion: Aug 2006
Sponsor: Vericel
Modality: Mesenchymal Stem Cells, Hematopoietic Stem Cells

Drugs: ixmyelocel-T
Conditions: degenerative spondylolisthesis (DS)

Overview

Phase 2, randomised, open-label trial of ixmyelocel-T in degenerative spondylolisthesis (DS) (2 arms), sponsored by Vericel. Primary endpoint: Radiographic evidence of bone fusion. Started Apr 2006; status: terminated.

Design

2 arms

Study design: RandomizedOpen-label

Control
Autologous bone graft
Treatment
ixmyelocel-T (BRC)

Who it enrols

Adults 18-75 eligible for single level posterolateral spinal fusion (L1-S1). Excludes BMI > 40, poorly controlled diabetes, osteoporosis, prior fusion at same level, and active infection.

Endpoints

Primary

Radiographic evidence of bone fusionThroughout duration of study

Secondary

Frequency and extent of callus or bone bridging6 months
Surgeon's evaluation of radiographic healing12 months
Reduction in pain scores at site of back surgeryFirst 3 months post-treatment
Use of prescription and non-prescription pain control drugsThroughout duration of study
Restoration of function for return to activities of normal daily living12 months

Beyond the preview

Go deeper on NCT00797550.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT00797550.