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Use of TRC Autologous Bone Marrow Cells in Posterolateral Lumbar Spine Fusion | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

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

NCT00797550•Vericel Corporation

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adults, 18-75 years of age
•Identified as eligible for elective surgery for single (1) level, posterolateral spinal fusion between L1 and S1 in which the spine stabilization is accomplished by pedicle screws and rod.
•Male patients and female patients (not pregnant or lactating). Patients should use an appropriate form of contraception while participating in the study.
•Patients able to give informed consent.
•Normal organ and marrow function

Exclusion Criteria

•Patients with hypophosphatasia, primary or secondary hyperparathyroidism caused by chronic renal insufficiency or osteomalacia.
•Patients with osteoporotic vertebral fractures.
•Patients with a prior spinal fusion at the level to be treated.
•Concomitant use of BMP, or devices containing BMP, or electronic growth stimulators.
•Any active infection of any clinical significance will be excluded from the study.
•Positive for HIV, HTLV and/or syphilis.
•Active Hepatitis B, or Hepatitis C infection at the time of enrollment.
•Known allergies to protein products (horse or bovine serum, or porcine trypsin) used in the ex-vivo cell production process.
•Patients who require systemic corticosteroid therapy after surgery.
•Pregnancy or lactation; positive of hCG.
+14 more criteria

Key Dates

Start Date

April 1, 2006

Primary Completion Date

August 1, 2006

Completion Date

October 1, 2008

Last Updated

May 11, 2021

Enrollment

ACTUAL participants

Conditions

Single Level Posterolateral Spinal Fusion

Interventions

Bone Repair Cells (BRCs)

BIOLOGICAL

Autologous bone graft

PROCEDURE