Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00424567
Status:
TERMINATED
Last Update Posted:
2021-05-11
First Post:
2007-01-18
Brief Title:
Feasibility Study of Aastrom Tissue Repair Cells to Treat Non-Union Fractures
Sponsor:
Vericel Corporation
Organization:
Vericel Corporation
Study Overview
Official Title:
TRC Autologous Bone Marrow Cells for the Treatment of Appendicular Skeletal Fracture Non-Union
Status:
TERMINATED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closed early for business reasons not safety reasons
Has Expanded Access:
True
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 patients 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None