Ignite Creation Date:
2024-05-05 @ 10:49 PM
Last Modification Date:
2024-10-26 @ 10:24 AM
Study NCT ID:
NCT01198080
Status:
COMPLETED
Last Update Posted:
2013-08-28
First Post:
2010-09-08
Brief Title:
Evaluate the Effect of Bone Marrow Derived Cd133 Cells in Patient With Osteonecrosis of Femoral Head
Sponsor:
Royan Institute
Organization:
Royan Institute
Study Overview
Official Title:
Bone Marrow Derived CD133 Stem Cells Transplantation in Femoral Head Osteonecrosis
Status:
COMPLETED
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Avascular necrosis is a disease where there is cellular death necrosis of bone components due to interruption of the blood supply Without blood the bone tissue dies and the bone collapses If avascular necrosis involves the bones of a joint it often leads to destruction of the joint articular surfaces Avascular necrosis is especially common in the hip joint A variety of methods are now used to treat avascular necrosis the most common being the total hip replacement or THRA new more promising treatment is hip resurfacing or metal on metal MOM resurfacingAnother treatment is utilization of bone marrow derived stem cellsthese stem cells can provide angiogenic factors and osteogenic cytokine to improve angiogenesis and bone formation
Detailed Description:
A vascular necrosis of femoral head is a debilitating disease resulting from interruption of blood supply to the bone This pathologic process results in the death of marrow and osteocytes and in its final stage femoral head collapse The most widespread treatment in the early stage of this disease is core decompression This surgical procedure involves drilling into the femoral neck through the necrotic area which reduces pressure within the bone and allows more blood vessels to form This study is designed to evaluate the clinical safety and efficacy of CD133 enriched bone marrow infusion adjacent with core decompression in patients with a vascular necrosis of femoral head Patients will undergo core decompression followed by CD133cell infusion into the cored area Clinical assessment includes a MRI Harries Hip ScoreSF36 Visual Analogue ScaleVAS and the WOMAC osteoarthritis Index
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