- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00797550
Use of TRC Autologous Bone Marrow Cells in Posterolateral Lumbar Spine Fusion
May 10, 2021 updated by: Vericel Corporation
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Phase 2
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
- 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.
- 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
- Patients that have undergone bisphosphonate therapy within the last 10 years.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control
The Control arm of the study will receive bone autograft.
|
|
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.
|
BRCs will be administered during spine fusion surgery
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Throughout duration of study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
Time Frame: Baseline, Month 6 and Month 12
|
Baseline, Month 6 and Month 12
|
To assess reduction in pain scores at site of back surgery
Time Frame: First 3 months post-treatment
|
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
Time Frame: Throughout duration of study
|
Throughout duration of study
|
To assess restoration of function for return to activities of normal daily living
Time Frame: Month 6 and Month 12
|
Month 6 and Month 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Harry Herkowitz, MD, William Beaumont Hospitals
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Primary Completion (Actual)
August 1, 2006
Study Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
November 24, 2008
First Submitted That Met QC Criteria
November 24, 2008
First Posted (Estimate)
November 25, 2008
Study Record Updates
Last Update Posted (Actual)
May 11, 2021
Last Update Submitted That Met QC Criteria
May 10, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ABI-55-0509-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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