Intra-Arterial Bone Marrow Mononuclear Cells (BM-MNCS) Transplantation in Acute Ischemic Stroke (IBiS Trial): Protocol of a Phase II, Randomized, Dose-Finding, Controlled Multicenter Trial

Abstract

This is the first trial to explore efficacy of different doses of intra-arterial bone marrow mononuclear cell in moderate-to-severe acute ischemic stroke patients. The trial is registered as NCT02178657.

Vascular precursor cells in tissue injury repair

“…The results suggest that this therapy is feasible and seems to be safe. A phase II, randomized, dose-finding, controlled multicenter trial on intra-arterial bone marrow cells transplantation in patients with acute ischemic stroke (IBIS trial) has been launched recently 319 .…”

Current Stage and Future Perspective of Stem Cell Therapy in Ischemic Stroke

“…In preclinical studies, no relevancy was reported for dose dependent functional outcome in NSCs therapy, but some clinical trials reported a better functional outcome correlated with increased dose of NSCs [41]. However, clinical trials were performed in the subacute phase and reported that the single cell dose not sufficient to improve the functional outcome (Table 1).…”

“…However, this study is limited by small sample size and heterogeneous group. Some clinical trials are carrying at the moment in order to test first trial to explore efficacy of different doses and delivery route of stem cells in stroke [41,43]. Clinical trials that reported an improved clinical outcome after stem cell therapy are summarized in Table 2.…”

“…If this potential can be generated by the type of stem cell or by delivery number of cells should be further established. However, other clinical trials that search for safety and afficacy of different stem cells are ongoing now [41,47]. Other clinical trials that were completed until now did not report tumor formation in humans after stem cell delivery [40].…”

TOOTH (The Open study Of dental pulp stem cell Therapy in Humans): Study protocol for evaluating safety and feasibility of autologous human adult dental pulp stem cell therapy in patients with chronic disability after stroke

“…16 To date, there are numerous published reports of early phase clinical trials using different types of stem cell therapy for stroke. [19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38] The majority used autologous precursor cells from the bone marrow with remainder using allogeneic neural and umbilicalderived stem cells.…”