Status:
TERMINATED
Feasibility Study of Aastrom Tissue Repair Cells to Treat Non-Union Fractures.
Lead Sponsor:
Vericel Corporation
Conditions:
Fracture, Ununited
Pseudarthrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
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. T...
Eligibility Criteria
Inclusion
- 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.
- 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
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
June 1 2007
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00424567
Start Date
October 1 2003
End Date
June 1 2007
Last Update
May 11 2021
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Illinois Bone and Joint Institute
Des Plaines, Illinois, United States, 60016
2
University of Michigan Medical School
Ann Arbor, Michigan, United States, 48109
3
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
4
Lutheran Medical Center
Brooklyn, New York, United States, 11220