Neurotransplantation of Fetal Porcine Cells in Patients with Basal Ganglia Infarcts: A Preliminary Safety and Feasibility Study

Abstract

Background: Cell transplantation is safe in animal models and enhances recovery from stroke in rats. Methods: We studied the safety and feasibility of fetal porcine transplantation in 5 patients with basal ganglia infarcts and stable neurological deficits. To prevent rejection, cells were pretreated with an anti-MHC1 antibody and no immunosuppressive drugs were given to the patients. Results: The first 3 patients had no adverse cell, procedure, or imaging-defined effects. The fourth patient had temporary worsening of motor deficits 3 weeks after transplantation, and the fifth patient developed seizures 1 week after transplantation. MRI in both patients demonstrated areas of enhancement remote from the transplant site, which resolved on subsequent imaging. Two patients showed improvement in speech, language, and/or motor impairments over several months and persisted at 4 years. The study was terminated by the FDA after the inclusion of 5 patients. Conclusion: This is the first report on the transplantation of nontumor cells in ischemic stroke patients.

Targeted Intra-arterial Transplantation of Stem Cells to the Injured CNS is more Effective than Intravenous Administration: Engraftment is Dependent on Cell Type and Adhesion Molecule Expression

“…clinical phase I and II studies (4,26). Cell-based therapies are in clinical trials in, for example, Parkinson's disease (13,14), ischemic stroke (4,21), and spinal cord Emerging stem cell therapies aimed at treatment of different central nervous system (CNS) disorders show lesions (29).…”

Clinical trial design for stem cell therapies in stroke: What have we learned?

“…There is considerable biological doubt, however, regarding the plausibility of modifying disability via cell engraftment, as noted above, and the justification for studying this group of patients has initially been based on stable neurological deficits offering a suitable environment for detection of any adverse effects. Older trials in this setting have used modified teratocarcinoma derived cells 41,42 or porcine xenografts, 43 neither cell type being developed further. The protocols from these older studies have formed the template for recent trials of direct intracerebral delivery.…”

Stem Cell Therapies in Ischemic Stroke

“…Çalışma 5 hastadan sonra sonlandırılmıştır (10 (16). Başka bir açık çalışmada ise allogeneik olarak elde edilmiş, modifiye, kemik iliği kaynaklı mezenkimal kök hücreler (SB623) 18 kronik inmeli hastaya uygulanmış, ve 12 ay takip sonunda belirgin düzelme rapor edilmiştir.…”