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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00797550
Recruitment Status : Terminated (Study was terminated early for business reasons (not safety reasons).)
First Posted : November 25, 2008
Last Update Posted : March 10, 2017
Information provided by:
Vericel Corporation

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.

Condition or disease Intervention/treatment Phase
Single Level Posterolateral Spinal Fusion Biological: Bone Repair Cells (BRCs) Procedure: Autologous bone graft Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of TRC Autologous Bone Marrow Cells in Posterolateral Lumbar Spine Fusion
Study Start Date : April 2006
Actual Primary Completion Date : August 2006
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Control
The Control arm of the study will receive bone autograft.
Procedure: Autologous bone graft
Experimental: Treatment
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)
BRCs will be administered during spine fusion surgery
Other Name: autologous bone marrow cells

Primary Outcome Measures :
  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. [ Time Frame: Throughout duration of study ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: Imaged by CT at 6 months after surgery ]
  2. 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 [ Time Frame: Baseline, Month 6 and Month 12 ]
  3. To assess reduction in pain scores at site of back surgery [ Time Frame: First 3 months post-treatment ]
  4. To assess use of prescription and non-prescription pain control and other drugs in treatment patients as compared to control patients [ Time Frame: Throughout duration of study ]
  5. To assess restoration of function for return to activities of normal daily living [ Time Frame: Month 6 and Month 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  • 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%).
  • Rationale for Exclusion of Certain Study Candidates

    1. 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.
    2. 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.
  • In the opinion of the investigator, the patient is unsuitable to cellular therapy or unable to continue with this study.
  • Patients that drink more than 2 alcoholic drinks per day or have a history of illicit drug use at the time of enrollment shall not be enrolled in the study.
  • Patient known to be non-euthyroid at baseline.
  • Patients undergoing active cancer therapy.
  • Bisphosphonate Therapy

    1. Patients that have undergone bisphosphonate therapy within the last 10 years.
    2. Initiation of bisphosphonate therapy in patients during this study is prohibited.
  • Patients with a known diagnosis of osteoporosis with recorded BMD less than -2.5.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00797550

Sponsors and Collaborators
Vericel Corporation
Principal Investigator: Harry Herkowitz, MD William Beaumont Hospitals

Responsible Party: Elmar Burchardt, MD, PhD, Aastrom Biosciences, Inc. Identifier: NCT00797550     History of Changes
Other Study ID Numbers: ABI-55-0509-1
First Posted: November 25, 2008    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017

Keywords provided by Vericel Corporation:
posterolateral spine fusion
bone graft