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

NCT00797550 | Terminated Phase 1

• 1 other identifier: ABI-55-0509-1
• Study Type: interventional
• Target: 2
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Single Level Posterolateral Spinal Fusion

Keywords

posterolateral spine fusion; bone graft

Outcome Measures

Primary Outcomes (1)

• 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.

  Throughout duration of study

Secondary Outcomes (5)

• To assess the relative efficacy of TRC graft compared to autologous vertebral bone graft based on the frequency and extent of callus or bone bridging between the adjacent decorticated vertebral processes on each side of the vertebrae.

  Imaged by CT at 6 months after surgery

• To assess surgeon's evaluation of radiographic healing at the site of surgery based on flexion and extension radiographs, as well as 2AP and lateral radiographs, and of clinical resolution

  Baseline, Month 6 and Month 12

• To assess reduction in pain scores at site of back surgery

  First 3 months post-treatment

• To assess use of prescription and non-prescription pain control and other drugs in treatment patients as compared to control patients

  Throughout duration of study

• To assess restoration of function for return to activities of normal daily living

  Month 6 and Month 12

Study Arms (2)

Control

ACTIVE COMPARATOR

The Control arm of the study will receive bone autograft.

Procedure: Autologous bone graft

Treatment

EXPERIMENTAL

The Treatment arm of the study will receive single level posterolateral spinal fusion between L1 to S1 levels with implantation of BRC product.

Biological: Bone Repair Cells (BRCs)

Interventions

Bone Repair Cells (BRCs) BIOLOGICAL

BRCs will be administered during spine fusion surgery

Also known as: autologous bone marrow cells

Treatment

Autologous bone graft PROCEDURE

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Body Mass Index (BMI) of 40 Kg/m2 or greater.
• Patients unable to tolerate general anesthesia defined as an ASA criteria of \>2.
• Patients with poorly controlled diabetes mellitus (HbA1C \>7%).
• 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.

Sponsors & Collaborators

• Vericel Corporation: lead

Study Officials

• Harry Herkowitz, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 24, 2008
• First Posted: November 25, 2008
• Study Start: April 1, 2006
• Primary Completion: August 1, 2006
• Study Completion: October 1, 2008
• Last Updated: May 11, 2021

Record last verified: 2021-05