Use of TRC Autologous Bone Marrow Cells in Posterolateral Lumbar Spine Fusion - Full Text View

Sponsored by:	Aastrom Biosciences
Information provided by:	Aastrom Biosciences
ClinicalTrials.gov Identifier:	NCT00797550

Purpose

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	Intervention	Phase
Single Level Posterolateral Spinal Fusion	Procedure: Bone Repair Cells (BRCs) with allogeneic, demineralized bone matrix Procedure: Spine fusion with autologous bone graft	Phase I Phase II

MedlinePlus related topics: Bone Grafts Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Use of TRC Autologous Bone Marrow Cells in Posterolateral Lumbar Spine Fusion

Further study details as provided by Aastrom Biosciences:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
To assess reduction in pain scores at site of back surgery [ Time Frame: First 3 months post-treatment ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
To assess restoration of function for return to activities of normal daily living [ Time Frame: Month 6 and Month 12 ] [ Designated as safety issue: No ]

Enrollment:	2
Study Start Date:	April 2006
Study Completion Date:	October 2008
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Control: Active Comparator The Control arm of the study will receive traditional bone autograft.	Procedure: Spine fusion with autologous bone graft
Treatment: Experimental The Treatment arm of the study will receive standard of care therapy, a bone marrow aspiration and single level posterolateral spinal fusion between L1 to S1 levels with implantation of TRC product.	Procedure: Bone Repair Cells (BRCs) with allogeneic, demineralized bone matrix BRCs will be administered during spine fusion surgery

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797550

Sponsors and Collaborators

Aastrom Biosciences

Investigators

Principal Investigator:

Harry Herkowitz, MD

William Beaumont Hospitals

More Information

No publications provided

Responsible Party:	Aastrom Biosciences, Inc. ( Elmar Burchardt, MD, PhD )
Study ID Numbers:	ABI-55-0509-1
Study First Received:	November 24, 2008
Last Updated:	November 24, 2008
ClinicalTrials.gov Identifier:	NCT00797550 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Aastrom Biosciences:

posterolateral spine fusion
bone graft

ClinicalTrials.gov processed this record on May 07, 2009