Browsing by Author "Wan Fariza Wan Jamaludin"
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- PublicationAutologous cells derived from different sources and administered using different regimens for 'no-option' critical lower limb ischaemia patients(John Wiley & Sons, Ltd., 2018)
;S Fadilah Abdul Wahid ;Nor Azimah Ismail ;Wan Fariza Wan Jamaludin ;Nor Asiah Muhamad ;Muhammad Khairul Azaham Abdul Hamid ;Hanafiah HarunarashidNai Ming LaiBackground: Revascularisation is the gold standard therapy for patients with critical limb ischaemia (CLI). In over 30% of patients who are not suitable for or have failed previous revascularisation therapy (the 'no-option' CLI patients), limb amputation is eventually unavoidable. Preliminary studies have reported encouraging outcomes with autologous cell-based therapy for the treatment of CLI in these 'no-option' patients. However, studies comparing the angiogenic potency and clinical e'ects of autologous cells derived from di'erent sources have yielded limited data. Data regarding cell doses and routes of administration are also limited. Objectives: To compare the e'icacy and safety of autologous cells derived from di'erent sources, prepared using di'erent protocols, administered at di'erent doses, and delivered via di'erent routes for the treatment of 'no-option' CLI patients. Search methods: The Cochrane Vascular Information Specialist (CIS) searched the Cochrane Vascular Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINEOvid, EmbaseOvid,the Cumulative Index toNursing and AlliedHealth Literature (CINAHL),the Allied and Complementary Medicine Database (AMED), and trials registries (16 May 2018). Review authors searched PubMed until February 2017. Selection criteria: We included randomised controlled trials (RCTs) involving 'no-option' CLI patients comparing a particular source orregimen of autologous cell-based therapy against another source or regimen of autologous cell-based therapy. Data collection and analysis: Three review authors independently assessed the eligibility and methodological quality ofthe trials.We extracted outcome data from each trial and pooled them for meta-analysis. We calculated e'ect estimates using a risk ratio (RR) with 95% confidence interval (CI), or a mean di'erence (MD) with 95% CI. - PublicationEfficacy and Safety of Autologous Cell-based Therapy in Patients with No-option Critical Limb Ischaemia: A Meta-Analysis(2018)
;Fadilah S. Abdul Wahid ;Nor Azimah Ismail ;Wan Fariza Wan Jamaludin ;Nor Asiah Muhamad ;Mohamad Azim Mohamad IdrisNai Ming LaiBackground: Revascularisation therapy is the current gold standard of care for critical limb ischemia (CLI), although a significant proportion of patients with CLI either are not fit for or do not respond well to this procedure. Recently, novel angiogenic therapies such as the use of autologous cellbased therapy (CBT) have been examined, but the results of individual trials were inconsistent. Objective: To pool all published studies that compared the safety and efficacy of autologous CBT derived from different sources and phenotypes with non cell-based therapy (NCT) in CLI patients. Methods: We searched Medline, Embase, Cochrane Library and ClinicalTrials.gov from 1974-2017. Sixteen randomised clinical trials (RCTs) involving 775 patients receiving the following interventions: mobilised peripheral blood stem cells(m-PBSC), bone marrow mononuclear cells(BM-MNC), bone marrow mesenchymal stem cells(BM-MSC), cultured BM-MNC(Ixmyelocel-T), cultured PB cells(VesCell) and CD34+ cells were included in the meta-analysis. Results: High-quality evidence (QoE) showed similar all-cause mortality rates between CBT and NCT. AR reduction by approximately 60% were observed in patients receiving CBT compared to NCT (moderate QoE). CBT patients experienced improvement in ulcer healing, ABI, TcO2, pain free walking capacity and collateral vessel formation (moderate QoE). Low-to-moderate QoE showed that compared to NCT, intramuscular BM-MNC and m-PBSC may reduce amputation rate, rest pain, and improve ulcer healing and ankle-brachial pressure index, while intramuscular BM-MSC appeared to improve rest pain, ulcer healing and pain-free walking distance but not AR. Efficacy of other types of CBT could not be confirmed due to limited data. Cell harvesting and implantation appeared safe and well-tolerated with similar rates of adverse-events between groups. Conclusion: Implantation of autologous CBT may be an effective therapeutic strategy for no-option CLI patients. BM-MNC and m-PSBC appear more effective than NCT in improving AR and other limb perfusion parameters. BM-MSC may be beneficial in improving perfusion parameters but not AR, however, this observation needs to be confirmed in a larger population of patients. Generally, treatment using various sources and phenotypes of cell products appeared safe and well tolerated. Large-size RCTs with long follow-up are warranted to determine the superiority and durability of angiogenic potential of a particular CBT and the optimal treatment regimen for CLI.