TerminatedPhase 1/2

Use of TRC Autologous Bone Marrow Cells in Posterolateral Lumbar Spine Fusion

Stopped: Study was terminated early for business reasons (not safety reasons).

2 participantsStarted 2006-04

Plain-language summary

The hypothesis is that Aastrom TRC autologous bone marrow tissue "grafts" can be safely used to promote bone healing as part of a single level posterolateral spine fusion surgical procedure.

Who can participate

Age range18 Years – 75 Years

SexALL

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Exclusion criteria

✕. Patients with other diseases are excluded to avoid confounding factors that might impact evaluation of safety and efficacy of TRC cell therapy in posterolateral spine fusion.
✕. More extensive surgery requiring more than one (1) level fusion is contraindicated in this study, to avoid confounding factors that might impact evaluation of safety and efficacy of TRC cell therapy.
✕. Patients that have undergone bisphosphonate therapy within the last 10 years.
✕. Initiation of bisphosphonate therapy in patients during this study is prohibited.

What they're measuring

The primary objective is to confirm that the TRC product, when used as a bone graft, is safe for use in posterolateral lumbar spinal fusion surgery, on the basis of defined radiographic evidence of bone fusion.

Timeframe: Throughout duration of study

Trial details

NCT IDNCT00797550

SponsorVericel Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-08

View on ClinicalTrials.gov More Single Level Posterolateral Spinal Fusion trials