Science and findings many times don't have a concluding phase. And the same goes with the heart stem cell theory. Numerous clinical trials have been attempted to test the benefits of using a patient’s own stem cells to treat heart disease. Results have been very conflicting; some claim real improvements in heart function, whilst others report none.
A group at Imperial College London investigated the possible reasons for this disparities and found strange but unexplained discrepancies within reports of many of the clinical trials.
- 133 reports of 49 clinical trials were investigated
- 600+ inconsistencies were found
- Disparities ranged from minor to serious mistakes and wrong data
- Reports with the most faults claimed most benefit to patients, while those without showed no improvement in patients’ health
Idea behind the study
Improvement in heart function is mainly measured by the increase of ejection fraction (EF).Bone marrow stem cells have been widely studied as a powerful therapeutic for patients who have suffered heart failure or heart attack.
Stem cells are taken from the patient’s own bone marrow and after treatment transplanted into the heart. This is an autologous therapy; Some claim real improvements whereas others report no improvement at all.
Improvement in heart function is routinely calculated by the increase of ejection fraction (EF)
In 2013, researchers from the National Heart and Lung Institute at Imperial College London analyzed 5 ground-breaking clinical trials. Each report on these trials claimed positive results for patients but numerous unexplained disparities were discovered. These findings prompted a deeper investigation by the DAMASCENE . Their aim was to find whether discrepancies in clinical trial methodologies and reporting are the reason for the mixed reported effects of this therapy.
What did this study reveal?
Clinical trials with more discrepancies in their reports also appeared to depict more effect of the treatment on patients. Discrepancies in trial reports were identified using meta-analysis. Its a statistical method used to compare results from different studies and by regression; measuring the results of each study based on the number of patients in the trial. In this way, the various sizes of the trials were taken into account; results from a trial of 100 patients would be considered double as influential as a trial with 50 patients.
This therapy is at the latent stage and is not a routine treatment for patients. Previously this therapy has been stated as safe, but more than 40 discrepancies have now been discovered in the reports from a clinical trial that tested safety. Although the main focus of this study was on discrepancies and their relationship to effectiveness of the treatment, separate issues were identified in some trials which suggest that well being should also be further investigated.
The results from this study on early phase trials suggest that it is not clear whether this therapy is effective in the treating heart disease. Clinical trial reports free from identifiable mistakes could be considered the most reliable but these have shown no positive effects in patient’s conditions. Two international phase III clinical trials have started recruiting participants in Europe and will focus on the efficacy of utilizing stem cells from the bone marrow to treat heart patients. However, if the findings from this new statistical study are correct, many previous clinical research reports could now be considered unreliable. This raises doubts over autologous bone marrow stem cell therapy as a valid powerful treatment for heart disease.
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