Safety and efficacy of bone marrow-derived autologous CD133+ stem cell therapy
Dale S Adler1, Hillard Lazarus, Ravi Nair
1Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Insights
Autologous bone marrow-derived CD133+ stem cell therapy is safe for patients with chronic total occlusion (CTO). This innovative treatment showed potential in improving ischemic heart conditions and reducing angina symptoms.
Area of Science:
- Cardiology
- Regenerative Medicine
- Stem Cell Therapy
Background:
- Chronic total occlusion (CTO) leads to myocardial ischemia and angina.
- Limited treatment options exist for CTO patients with significant ischemia.
- Autologous stem cell therapy offers a potential regenerative approach.
Purpose of the Study:
- To assess the safety and feasibility of intracoronary infusion of autologous bone marrow (BM)-derived CD133+ stem cells.
- To evaluate the efficacy of this therapy in patients with CTO and ischemia.
Main Methods:
- Phase I dose-escalating clinical study.
- Intracoronary infusion of autologous CD133+ stem cells into epicardial vessels.
- Follow-up for 24 months post-infusion.
Main Results:
- No major adverse cardiac events (MACE), revascularization, or hospital readmissions for angina.
- No periprocedural complications, including arrhythmias or neurologic events.
- Improvement in ischemic myocardium and a trend towards reduced anginal symptoms.
Conclusions:
- Intracoronary infusion of autologous CD133+ stem cells is safe and feasible for CTO patients.
- The therapy shows promise in improving myocardial ischemia and reducing angina.
- Further Phase II/III trials are warranted to confirm efficacy.
Abstract:
The Phase I clinical study was designed to assess the safety and feasibility of a dose escalating intracoronary infusion of autologous bone marrow (BM)-derived CD133+ stem cell therapy to the patients with chronic total occlusion (CTO) and ischemia. Nine patients were received CD133+ cells into epicardial vessels supplying collateral flow to areas of viable ischemic myocardium in the distribution of the CTO. There were no major adverse cardiac events (MACE), revascularization, re-admission to the hospital secondary to angina, or acute myocardial infarction (AMI) for the 24-month period following cellular infusion. In addition, there were no periprocedural infusion-related complications including malignant arrhythmias, loss of normal coronary blood flow or acute neurologic events. Cardiac enzymes were negative in all patients. There was an improvement in the degree of ischemic myocardium, which was accompanied by a trend towards reduction in anginal symptoms. Intracoronary infusion of autologous CD133+ marrow-derived cells is safe and feasible. Cellular therapy with CD133+ cells to reduce anginal symptoms and to improve ischemia in patients with CTO awaits clinical investigation in Phase II/III trials.
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