The purpose of this study is to evaluate the safety and efficacy of autologous bone marrow stem cells in sickle cell disease patients with osteonecrosis
The aim of this study is to evaluate autologous bone marrow stem cells transplantation as a safe and potentially beneficial treatment for sickle cell disease patients with osteonecrosis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
All patients will undergo autologous bone marrow stem cell implantation into the necrotic lesion area using a minimally invasive technique.
Change in Functional / Clinical Score of 10 points or more
Standardized and objective scoring system to rate patient's functional abilities
Time frame: 60 months
Numeric pain intensity scale (0-10)
VAS scoring system
Time frame: 60 months
Disease progression defined as progression to a fractural stage of osteonecrosis
Radiographic signals
Time frame: 60 months
Reoperation rate
Need for further surgery or hip replacement
Time frame: 60 months
Radiological progression
Radiological progression is defined according to the development of the Ficat- and Steinberg-staging system of osteonecrosis. It is based on radiological findings in X-Ray and MRI scans, respectively, and it is useful in predicting outcomes.
Time frame: 60 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.