Fracture, UnunitedPhase 1/2NCT00424567
Feasibility Study of Aastrom Tissue Repair Cells to Treat Non-Union Fractures.
A Phase 1/2 study testing Fracture surgery and Cultured Bone Marrow Tissue in people with Fracture, Ununited and Pseudarthrosis, run by Vericel Corporation at 4 sites in United States.
Trial summary
The purpose of this multi-center study is to obtain clinical data to substantiate that Aastrom TRC autologous bone marrow cells will regenerate bone in patients with established (appendicular skeletal) non union fractures, when used with one of the commonly employed commercially available allograft chip matrices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture, Ununited, Pseudarthrosis
- What is being tested?
- Fracture surgery and Cultured Bone Marrow Tissue
- Type of treatment
- Surgery or procedure
- How many people
- 36 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2003to Jun 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type IIIA or IIIB fracture
- Fracture gap < 6 cm.
- Distance of > 4 cm from joint
- No clinical signs of infection at the wound site or fracture site.
- Adult patients >18 years of age.
- Male patients or female patients who are not pregnant or lactating.
Show all 13Show fewer
- Patients must have normal organ and marrow function as defined below:
- Leukocytes >=3000/microliters
- Absolute neutrophil count >=1500/microliters
- Platelets >=100,000/microliters
- AST (SGOT)/ALT (SGPT) <2.5 x institutional limits
- Creatinine within normal limits or creatinine clearance calculated)>=60 mL/min/1.73 square miter with creatinine above institutional normal.
- Patients able to give informed consent
Who cannot join
- Other long bone fractures, e.g clavicle
- Patients unable to discontinue ethanol use after surgery including those requiring pharmacologic adjuvant assistance.
- Although not an exclusion criteria, the attending physician shall discuss with the patient the advantages of discontinuing smoking cigarettes and/or cigars during the term of the study including discontinuing the use of pharmacologic adjuvant assistance such as nicotine suppression.
- The use or discontinuance of ethanol and/or cigarettes/cigars will be noted in the patient's case report forms.
- Patients who require corticosteroid anti-inflammatory therapy after surgery.
- Patients with genetic metabolic bone disease such as hypophosphatasia, or metabolic bone disorders such as primary or secondary hyperparathyroidism caused by chronic renal insufficiency or other disorders.
Show all 12Show fewer
- Patients unable to tolerate general anesthesia defined as an ASA criteria of 0 or 1.
- Patients on systemic antibiotics for suspected wound or fracture site infection.
- Patients with diabetes.
- Glasgow score of < 13.
- Injury severity score of > 25.
- Allergy to protein products derived from mammalian sources (horse, bovine or porcine) required in the ex-vivo cell production process.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Michigan Medical School
Ann Arbor, Michigan, 48109
Lutheran Medical Center
Brooklyn, New York, 11220
Illinois Bone and Joint Institute
Des Plaines, Illinois, 60016
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Official title: TRC Autologous Bone Marrow Cells for the Treatment of Appendicular Skeletal Fracture Non-Union
The purpose of this multi-center study is to obtain clinical data to substantiate that Aastrom TRC autologous bone marrow cells will regenerate bone in patients with established (appendicular skeletal) non union fractures, when used with one of the commonly employed commercially available allograft chip matrices.
Read the detailed description
The current standard of care for regeneration of atrophic long bone fracture non-union is autologous bone and marrow chiseled from the patient's iliac crest in open surgery under general anesthesia. This method for harvesting bone and marrow is associated with substantial morbidity of long-term pain, the possibility of deep-seated infection at the site of the bone harvest and other indirect consequences such as extended time of surgery, substantial expense and the potential for blood transfusion. The procedure is also associated with a bone graft failure rate of at least 20%.
Due to the substantial morbidity resulting from the aggressive open surgical procedure, alternatives are sought. Current alternatives to autologous bone include commercially available synthetic, xenograft and allograft matrices, either used alone or combined with bone autograft. Cell-free substitutes, such as matrices combined with platelet rich plasma or recombinant bone morphogenic proteins for osteoinductivity, are also used. These alternatives, although less morbid than a full bone harvest, have not yet been stringently determined to be equivalent. Therefore, there is a continuing search for additional improved alternatives.
Aastrom Biosciences, Inc. has developed a unique process for growing human bone marrow, including the early stem cell populations, from small samples of percutaneously aspirated bone marrow. The process is carried out in the AastromReplicell Cell Production System (ARS).
The study will be performed to obtain clinical data to substantiate that Aastrom TRC autologous bone marrow cells will regenerate bone in patients with established non union fractures, when used with one of the commonly employed commercially available allograft chip matrices.
The bone marrow cells will be obtained by a brief, percutaneous, small volume aspiration (approximately 30 - 50 ml) from the posterior iliac crest obtained under local and conscious sedation. Percutaneous marrow aspiration is substantially less morbid and time consuming than the current open surgical process of bone autograft harvest.
The study will treat up to 36 patients (11 in the first group and 25 in a second group).
Patients will be treated using standard surgical procedures for the treatment of non union fractures (including commonly used hardware needed to stabilize the fracture). The processed cells will be mixed with commercially available bone matrix during surgery and placed in the area of the fracture.
Patients will be monitored for 12 months following the surgery.
- Conditions
- Fracture, Ununited, Pseudarthrosis
- Being tested
- Fracture surgery, Cultured Bone Marrow Tissue
- Keywords
- Fracture, non union fracture, ununited fracture, pseudarthrosis
- Medical subject headings
- Fractures, Ununited, Pseudarthrosis, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fracture surgeryProcedure or surgery
Cultured Bone Marrow TissueDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be the proportion of patients with demonstrated healing, including bone formation, at 12 months (or until completely healed) from surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2007 (estimated)
- Study startOct 2003
- Study completionJun 2007
Why it stopped: Closed 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 Fracture, UnunitedStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- Vericel Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Matthew Jimenez, MD, Principal investigator, Illinosis Bone and Joint InstituteJames Goulet, MD, Principal investigator, University of MichiganThomas Lyon, MD, Principal investigator, Lutheran Medical CenterNowinski, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00424567
- Sponsor's protocol ID
- ABI 55-0503-1
- Status last verified
- May 2021
- First submitted
- 18 Jan 2007
- Last updated
- 11 May 2021
- Results posted
- No
- Expanded access
- Available
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
- TRC Autologous Bone Marrow Cells for the Treatment of Appendicular Skeletal Fracture Non-Union
- ClinicalTrials.gov ID
- NCT00424567
- Acronym / sponsor ID
- ABI 55-0503-1
- Conditions
- Fracture, Ununited, Pseudarthrosis
- Keywords
- Fracture, non union fracture, ununited fracture, pseudarthrosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed early for business reasons (not safety reasons)
- Enrolment
- 36 participants
- Lead sponsor
- Vericel CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Study completion
- Jun 2007
- First posted
- 19 Jan 2007 (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 purpose of this multi-center study is to obtain clinical data to substantiate that Aastrom TRC autologous bone marrow cells will regenerate bone in patients with established (appendicular skeletal) non union fractures, when used with one of the commonly employed commercially available allograft chip matrices.
Detailed description
The current standard of care for regeneration of atrophic long bone fracture non-union is autologous bone and marrow chiseled from the patient's iliac crest in open surgery under general anesthesia. This method for harvesting bone and marrow is associated with substantial morbidity of long-term pain, the possibility of deep-seated infection at the site of the bone harvest and other indirect consequences such as extended time of surgery, substantial expense and the potential for blood transfusion. The procedure is also associated with a bone graft failure rate of at least 20%.
Due to the substantial morbidity resulting from the aggressive open surgical procedure, alternatives are sought. Current alternatives to autologous bone include commercially available synthetic, xenograft and allograft matrices, either used alone or combined with bone autograft. Cell-free substitutes, such as matrices combined with platelet rich plasma or recombinant bone morphogenic proteins for osteoinductivity, are also used. These alternatives, although less morbid than a full bone harvest, have not yet been stringently determined to be equivalent. Therefore, there is a continuing search for additional improved alternatives.
Aastrom Biosciences, Inc. has developed a unique process for growing human bone marrow, including the early stem cell populations, from small samples of percutaneously aspirated bone marrow. The process is carried out in the AastromReplicell Cell Production System (ARS).
The study will be performed to obtain clinical data to substantiate that Aastrom TRC autologous bone marrow cells will regenerate bone in patients with established non union fractures, when used with one of the commonly employed commercially available allograft chip matrices.
The bone marrow cells will be obtained by a brief, percutaneous, small volume aspiration (approximately 30 - 50 ml) from the posterior iliac crest obtained under local and conscious sedation. Percutaneous marrow aspiration is substantially less morbid and time consuming than the current open surgical process of bone autograft harvest.
The study will treat up to 36 patients (11 in the first group and 25 in a second group).
Patients will be treated using standard surgical procedures for the treatment of non union fractures (including commonly used hardware needed to stabilize the fracture). The processed cells will be mixed with commercially available bone matrix during surgery and placed in the area of the fracture.
Patients will be monitored for 12 months following the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Type IIIA or IIIB fracture
- Fracture gap < 6 cm.
- Distance of > 4 cm from joint
- No clinical signs of infection at the wound site or fracture site.
- Adult patients >18 years of age.
Key exclusion criteria (12 listed)
- Other long bone fractures, e.g clavicle
- Patients unable to discontinue ethanol use after surgery including those requiring pharmacologic adjuvant assistance.
- Patients who require corticosteroid anti-inflammatory therapy after surgery.
- Patients with genetic metabolic bone disease such as hypophosphatasia, or metabolic bone disorders such as primary or secondary hyperparathyroidism caused by chronic renal insufficiency or other disorders.
- Patients unable to tolerate general anesthesia defined as an ASA criteria of 0 or 1.
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 |
|---|---|---|
| Fracture surgery | Procedure or surgery | – |
| Cultured Bone Marrow Tissue | Drug | – |
Primary outcome
The primary endpoint will be the proportion of patients with demonstrated healing, including bone formation, at 12 months (or until completely healed) from surgery.
Results and safety
The study was stopped early (reason given: Closed 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.
Related trials for Fracture, Ununited
Not yet recruiting
Allograft vs. Autograft Nonunion
Nonunion Fracture
RecruitingObservational study
Exactech Proximal Humerus Fracture Plate System Post Market Clinical Follow-up
Proximal Humeral Fracture, Fracture Dislocation
RecruitingObservational study
Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care
Fractures, Bone, Nonunion of Fracture
RecruitingPhase 3
PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation
Infections, Infected Wound
Active, not recruiting
Lumbar Fusion With Porous Versus Non-Porous Cages
Spinal Fusion, Lumbar Fusion
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.
Matthew Jimenez, MD principal investigator
Illinosis Bone and Joint Institute
James Goulet, MD principal investigator
University of Michigan
Thomas Lyon, MD principal investigator
Lutheran Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fracture surgery and Cultured Bone Marrow Tissue in people with Fracture, Ununited and Pseudarthrosis, run by Vericel Corporation at 4 sites in United States.
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 13 inclusion and 12 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.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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: Closed 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 endpoint will be the proportion of patients with demonstrated healing, including bone formation, at 12 months (or until completely healed) from surgery.. 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.