Single Level Posterolateral Spinal FusionPhase 1/2NCT00797550
Use of TRC Autologous Bone Marrow Cells in Posterolateral Lumbar Spine Fusion
A Phase 1/2 study testing Bone Repair Cells (BRCs) and Autologous bone graft in people with Single Level Posterolateral Spinal Fusion, run by Vericel Corporation.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Single Level Posterolateral Spinal Fusion
- What is being tested?
- Bone Repair Cells (BRCs) and Autologous bone graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Oct 2008
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
About this study
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.
- Being tested
- Bone Repair Cells (BRCs), Autologous bone graft
- Keywords
- posterolateral spine fusion, bone graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Repair Cells (BRCs)Biological
Also called autologous bone marrow cells
BRCs will be administered during spine fusion surgery
Autologous bone graftProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | The Control arm of the study will receive bone autograft. Receives: 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. Receives: Biological: Bone Repair Cells (BRCs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: Baseline, Month 6 and Month 12
To assess reduction in pain scores at site of back surgery
Measured: 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
Measured: Throughout duration of study
To assess restoration of function for return to activities of normal daily living
Measured: Month 6 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startApr 2006
- Primary completionAug 2006
- Study completionOct 2008
Why it stopped: Study was terminated early for business reasons (not safety reasons).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single Level Posterolateral Spinal FusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vericel Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Harry Herkowitz, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797550
- Sponsor's protocol ID
- ABI-55-0509-1
- Status last verified
- May 2021
- First submitted
- 24 Nov 2008
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of TRC Autologous Bone Marrow Cells in Posterolateral Lumbar Spine Fusion
- ClinicalTrials.gov ID
- NCT00797550
- Acronym / sponsor ID
- ABI-55-0509-1
- Keywords
- posterolateral spine fusion, bone graft
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated early for business reasons (not safety reasons).
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Vericel CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 25 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Autologous bone graftThe Control arm of the study will receive bone autograft. |
| Treatment | Experimental | Biological: Bone Repair Cells (BRCs)The Treatment arm of the study will receive single level posterolateral spinal fusion between L1 to S1 levels with implantation of BRC product. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone Repair Cells (BRCs)Also: autologous bone marrow cellsBRCs will be administered during spine fusion surgery | Biological | Treatment |
| Autologous bone graft | Procedure or surgery | Control |
Primary outcome
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
5 secondary outcomes
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
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
To assess reduction in pain scores at site of back surgery
Time frame: 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
To assess restoration of function for return to activities of normal daily living
Time frame: Month 6 and Month 12
Results and safety
The study was stopped early (reason given: Study was terminated early for business reasons (not safety reasons).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry Herkowitz, MD principal investigator
Corewell Health East
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bone Repair Cells (BRCs) and Autologous bone graft in people with Single Level Posterolateral Spinal Fusion, run by Vericel Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study was terminated early for business reasons (not safety reasons).). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.