A randomized, controlled study of autologous therapy with bone marrow-derived aldehyde dehydrogenase bright cells in patients with critical limb ischemia

2011 ◽  
Vol 78 (7) ◽  
pp. 1060-1067 ◽  
Author(s):  
Emerson C. Perin ◽  
Guilherme Silva ◽  
Amir Gahremanpour ◽  
John Canales ◽  
Yi Zheng ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Aldehyde Dehydrogenase ◽  
Critical Limb Ischemia ◽  
Limb Ischemia ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Autologous Therapy

scholarly journals 10-year follow-up results of the prospective, double-blinded, randomized, controlled study on autologous bone marrow buffy coat grafting combined with core decompression in patients with avascular necrosis of the femoral head

2020 ◽  
Author(s):  
Mengyuan Li ◽  
Yuanchen Ma ◽  
Guangtao Fu ◽  
Ruiying Zhang ◽  
Qingtian Li ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Core Decompression ◽  
Autologous Bone Marrow ◽  
Buffy Coat ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Autologous Bone ◽  
Double Blinded

Abstract Background: Avascular necrosis of the femoral head (ANFH) is a severely disabling disease of the hip. Several clinical trials have shown promising outcomes on the use of mesenchymal stem cells for the treatment of ANFH, but long-term clinical assessments are lacking. Previously, we reported the two-year follow-up results of a prospective, double-blinded, randomized, controlled study on autologous bone marrow buffy coat grafting combined with core decompression in patients with ANFH. Here, we report the ten-year follow-up results of this study.Methods: We recruited 43 (53 hips) patients from 2009 to 2010. The hips were randomly allocated to code decompression (CD) with or without bone marrow buffy coat (BBC) grafting. Participants underwent follow-up at 24, 60, and 120 months postoperatively. The visual analogue scale (VAS), Lequesne algofunctional index and Western Ontario and McMaster Universities Arthritis Index (WOMAC) osteoarthritis scores were recorded. Survival rate analysis and prognostic factor analysis were performed. The endpoint was defined as progression to Ficat stage IV or conversion to hip arthroplasty.Results: A total of 31 patients (41 hips) were included in the final analysis. The CD + BBC group had better subjective assessment scores than the CD group. The average survival times were 102.3 months and 78.1 months in the CD + BBC group and CD group, respectively (log-rank test, P = 0.029). In the univariate Cox proportional hazards regression model, age [hazards ratio (HR) = 1.079, P = 0.047] and preoperative Ficat stage (HR = 3.283, P = 0.028) indicated a high risk for progression, while the use of BBC (HR = 0.332, P = 0.042) indicated a low risk. Preoperative Ficat stage III was isolated as an independent risk factor for clinical failure in the multivariate model (HR = 3.743, P = 0.018).Conclusion: The ten-year follow-up results of this prospective, double-blinded, randomized, controlled study showed that the use of autologous BBC in combination with core decompression was more effective than the use of core decompression alone.Trial Registration: ClinicalTrials.gov identifier NCT01613612. Registered 13 December 2011 – Retrospectively registered, https://clinicaltrials.gov/ct2/show/record/NCT01613612.

scholarly journals 10-year Follow-up of the Prospective, Double-blinded, Randomized, Controlled Study of Autologous Bone Marrow Buffy Coat Grafting Combined With Core Decompression in Patients With Avascular Necrosis of Femoral Head

2020 ◽  
Author(s):  
Mengyuan Li ◽  
Yuanchen Ma ◽  
Guangtao Fu ◽  
Ruiying Zhang ◽  
Qingtian Li ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Core Decompression ◽  
Autologous Bone Marrow ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Autologous Bone ◽  
Double Blinded ◽  
Necrosis Of Femoral Head

Abstract Background: Avascular necrosis of femoral head (ANFH) is a severely disabling disease of hip.Several clinical trials have shown promising outcomes on the use of mesenchymal stem cells for treatment of ANFH but long-term clinical assessment is lacking. Previously we have reported two year follow up of a prospective, double-blinded, randomized, controlled study of autologous bone marrow buffy coatgrafting combined with core decompression in patients with ANFH. Here we reported the outcome of ten year follow up on the study.Methods:We recruited 43 (53 hips) patients from 2009 to 2010. The hips were randomly allocated to code decompression (CD) with and without bone marrowbuffy coat (BBC). Participants were followed at 24, 60, 120 months postoperatively. Visual analogue scale (VAS), Lequesne algofunctional index and Western Ontario and McMaster Universities Arthritis Index (WOMAC) osteoarthritis scoring were recorded. Survival rate analysis and the prognostic factor analysis were performed. The endpoint was defined as progression to Ficat stage IV or conversion to hip arthroplasty.Results: 31 patients (41 hips) were included in the final analysis. CD + BBC group scored better in subjective assessing scores compared with CD group. The average survival time was 102.3 months and 78.1 months for CD + BBC group and CD group, respectively (Log-rank test, P = 0.029). In the univariate COX proportional-hazards regression model, age [hazards ratio (HR) = 1.079, P = 0.047] and pre-operative Ficat stage (HR = 3.283, P = 0.028) indicated high risk for progression, while the use of BBC (HR = 0.332, P = 0.042) indicated low risk. Pre-operative Ficat stage IIIwas isolated as an independent risk factor for clinical failure in the multivariate model (HR = 3.743, P = 0.018).Conclusion: The outcome of ten year follow up on this prospective, double-blinded, randomized,controlled study showed that use of the autologous BBC in combined with core decompression is more effective than core decompression alone.TrialRegistration: ClinicalTrials.gov identifier NCT01613612. Registered 13 December 2011 – Retrospectively registered, https://clinicaltrials.gov/ct2/show/record/NCT01613612.

A Randomized Controlled Study of Consultation for Students With Autism: Impact of Web Technology

2012 ◽  
Author(s):  
Lisa A. Ruble ◽  
John H. McGrew ◽  
Michael D. Toland
Keyword(s):  
Web Technology ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Students With Autism

Foreign language learning in older age does not improve memory or intelligence: Evidence from a randomized controlled study.

2020 ◽  
Vol 35 (2) ◽  
pp. 212-219
Author(s):  
Rasmus Berggren ◽  
Jonna Nilsson ◽  
Yvonne Brehmer ◽  
Florian Schmiedek ◽  
Martin Lövdén
Keyword(s):  
Foreign Language ◽  
Language Learning ◽  
Foreign Language Learning ◽  
Older Age ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Randomized Controlled

Prevention of Surgical Site Sternal Infections in Cardiac Surgery: A Two-center Prospective Randomized Controlled Study

2016 ◽  
Vol 64 (S 01) ◽  
Author(s):  
C. Schimmer ◽  
E. Ramm ◽  
G. Hoffmann ◽  
B. Panholzer ◽  
R. Leyh ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Randomized Controlled
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