Feasibility Study of Aastrom Tissue Repair Cells to Treat Non-Union Fractures.
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.
Procedure: Fracture surgery
Drug: Cultured Bone Marrow Tissue
Aastrom Biosciences has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||TRC Autologous Bone Marrow Cells for the Treatment of Appendicular Skeletal Fracture Non-Union|
- The primary endpoint will be the proportion of patients with demonstrated healing, including bone formation, at 12 months (or until completely healed) from surgery.
|Study Start Date:||October 2003|
|Estimated Study Completion Date:||June 2007|
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.
|United States, Illinois|
|Illinois Bone and Joint Institute|
|Des Plaines, Illinois, United States, 60016|
|United States, Michigan|
|University of Michigan Medical School|
|Ann Arbor, Michigan, United States, 48109|
|William Beaumont Hospital|
|Royal Oak, Michigan, United States, 48073|
|United States, New York|
|Lutheran Medical Center|
|Brooklyn, New York, United States, 11220|
|Principal Investigator:||Matthew Jimenez, MD||Illinosis Bone and Joint Institute|
|Principal Investigator:||James Goulet, MD||University of Michigan|
|Principal Investigator:||Thomas Lyon, MD||Lutheran Medical Center|
|Principal Investigator:||Nowinski, MD||William Beaumont Hospitals|