Skóra Jan, Pupka Artur, Barć Piotr, Szyber Przemysław, Polak Wojciech, Szyber Piotr
Akademia Medyczna we Wrocławiu, Katedra i Klinika Chirurgii Naczyniowej, Ogólnej i Transplantacyjnej.
Pol Merkur Lekarski. 2007 Feb;22(128):121-5.
The paper presents the results of our hybrid gene-cell therapy in case of critical lower limb ischemia. Eighteen patients with critical limb ischemia were enrolled to the study. The bone marrow from each patient was harvested. It had been incubated with VEGF165 gene plasmid for two hours before it was administrated intramuscularly into patient's lower limb.
In the study we evaluated: safety, clinical outcomes of the therapy, venous blood VEGF protein concentration before and after (at: 7th, 14th, 28th and 90th day) administration of the stem cells. We obtained samples of muscles from the patients who underwent the limb amputation, which were examined histological and by PCR (Polymerase Chain Reaction) for detection of plasmid genes.
We observed very good clinical outcomes of the therapy. In ten of eighteen patients (-55%) critical lower limb ischemia symptoms subsided--they saved their limbs. The serum VEGF concentration was higher than in healthy controls (p < 0.05). We observed the increase of the concentration of the cytokine at the 14th day an decrease at the 90th day after administration of cells with plasmid. We found expression of plasmid VEGF in transfected stem cells and in tissues taken from amputated limbs. However histological examination did not reveal any sings of new blood vessels formation in the samples taken from ischemic limbs.
The therapy is safe and effective. We observed significant improvement in patient's clinical state. The therapy needs further investigations.
本文介绍了我们在严重下肢缺血病例中采用的混合基因 - 细胞疗法的结果。18例严重肢体缺血患者被纳入该研究。采集每位患者的骨髓。在将其肌肉注射到患者下肢之前，先与VEGF165基因质粒孵育两小时。
在该研究中，我们评估了：安全性、治疗的临床结果、干细胞给药前后（第7天、14天、28天和90天）静脉血VEGF蛋白浓度。我们从接受肢体截肢的患者身上获取肌肉样本，进行组织学检查并通过PCR（聚合酶链反应）检测质粒基因。
我们观察到该治疗具有非常好的临床效果。18例患者中有10例（-55%）严重下肢缺血症状缓解——保住了肢体。血清VEGF浓度高于健康对照组（p < 0.05）。我们观察到在给予含质粒的细胞后第14天细胞因子浓度升高，第90天降低。我们在转染的干细胞和从截肢肢体获取的组织中发现了质粒VEGF的表达。然而，组织学检查未在缺血肢体获取的样本中发现任何新血管形成的迹象。
该治疗安全有效。我们观察到患者的临床状态有显著改善。该治疗需要进一步研究。
