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Osiris Therapeutics (OSIR)公司昨天发表为期6个月的临床实验第一期的数据，评估成人间叶干细胞(mesenchymal stem cells，MSC)疗法Provacel，治疗心脏疾病的效果。研究采双盲试验(double-blind，也就是医生及病人都不知道用药为何)进行，在53位病人的研究当中，评估静脉注射Provacel的安全性与疗效。结果显示接受此种治疗的病患能降低心脏病相关疾病，例如：心律不整的机率，并能大幅改善病人的心肺功能。此研究发表于American College of Cardiology’s Innovation in Intervention。
比较注射Provacel的病人与注射安慰剂的病人，其心律不整的发生率分别为9%及37%，显示Provacel组病人的情况改善了75%，而整体心肺功能的改善情况则分别为42%及11%。Rush大学医学中心的心脏病学家Dr.Gary Schaer说：「研究结果之所以如预期的好，其中一个原因是因为这些干细胞不需形成组织即可被利用，此外，也不会引发免疫反应，可适用于每个病人。」
间叶干细胞(Mesenchymal stem cells)存在成人的骨髓中，深具潜力分化为成熟的心脏细胞及血液细胞。由于这些细胞在很早期就被分化出来，因此，几乎不会引起免疫反应，与O型血的情况很类似，可以给任何人使用。另外一个利基点是这些干细胞能由标准静脉注射法完成，因此，能免除插入导管或手术等程序，对病人来说十分简便。
Schaer医师表示：「在不同的环境及控制条件下，MSC能分化成各式不同的细胞，且增殖的细胞数目量很多，通常一个赠予者提供的细胞就能治疗数千个病人，且这些MSC细胞能在冷冻状态下贮存超过数年之久，以供病人需求时使用。」OSIR总裁兼执行长C. Randal Mills博士说：「临床试验第一期的研究结果，让我们对于Provacel的安全性很有信心，并期望后续的试验也能看到更好的结果。」
(资料来源 : Bio.com)
英文原文：
Heart Attack Patients Treated With Novel Stem Cell Therapy Experience Significant Improvement in Heart and Lung Function
03/28/07 -- Heart attack patients who received an new intravenous adult stem cell therapy, Provacel, experienced a lower number of adverse events, such as cardiac arrhythmias, and had significant improvements in heart, lung and global function compared to those who received a placebo, according to six-month Phase I study data presented at the American College of Cardiology's Innovation in Intervention: i2Summit in New Orleans.
Rush was one of 10 premier cardiac centers across the country that participated in the 53-patient, double-blind, placebo-controlled trial. Among other findings, patients receiving Provacel were 75 percent less likely to experience an arrhythmic adverse event compared to those receiving placebo (9 % vs. 37%, p=0.025) and significantly more patients who received Provacel experienced improvement in their overall condition at six months as compared to those receiving placebo (42% vs. 11%, p=0.027).
Provacel is a preparation of adult stem cells pre-formulated for intravenous delivery by the drug's manufacture, Osiris Therapeutics. Patients were administered an infusion of either Provacel or placebo within 10 days of having a heart attack and are being followed for 2 years. To prevent bias, neither the patient nor the physician knows who received the stem cell treatment and who received placebo.
Rush principal investigator cardiologist Dr. Gary Schaer, head of the Rush Cardiac Catheterization Laboratory, says one reason the study results are so promising is that these stem cells can be used without tissue typing and do not trigger an immune response, and are available for every patient.
The mesenchymal stem cells (MSC) are found in the adult bone marrow and have the potential to develop into mature heart cells and new blood vessels. The MSC cells are derived from normal, healthy adult volunteer bone marrow donors and are not derived from a fetus, embryo or animal. Because they are in an early stage of development, it is believed that they do not trigger an immune response when placed in someone else's body.
Similar to Blood Type O, these MSCs are being used without tissue type matching to a specific patient.
A unique benefit of the stem cell product is that it is given to patients through a standard IV line. Other therapies require delivery to the site of the disease through catheterization or open surgical procedures, but this one was very simple and easy for the patient.
Schaer says the cells were grown in culture to very high numbers, allowing a single donor's cells to treat thousands of patients. \"The cells have the ability to expand, or multiply, under controlled conditions, and the expanded cells have the ability to develop into different types of cells in the appropriate environment. One donation can produce billions of MSCs. The cells can be stored for years in a frozen state, ready to be used when they are needed.\"
Adult stem cells are designed by nature to perform tissue repair in a mature adult. It is believed that these cells can be used in patients unrelated to the donor, without rejection, eliminating the need for donor matching and recipient immune suppression. Once transplanted, the cells promote healing of damaged or diseased tissues.
\"Because of the participation by top tier sites such as Rush University Medical Center, we were able to conduct a study that was exceptionally well planned and executed\" said C. Randal Mills Ph.D., President and CEO of Osiris Therapeutics. \"We were confident in the safety profile given our previous experience using the intravenous form of these stem cells to treat other diseases in later stage clinical trials. However, we did not expect to see the across-the-board clinical improvement observed in patients at this early stage of testing.\" |
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发表于 2007-7-13 00:49:03