Neurology: Chronic brain trauma cell therapy

A recent study published in Neurology, an authoritative journal in the field of neurology, aims to determine whether the implantation of an allogeneic modified bone marrow-to-bone marrow-filled substitut/stem cell (SB623) can improve chronic motor dysfunction secondary to brain trauma (TBI).
The one-year, two-blind, randomized, fake surgically controlled Phase 2 trial (NCT02416492) conducted a midterm analysis at the 6th month to assess the safety and efficacy of stereotactic intracranial implantation of SB623 in patients with chronic motor dysfunction who were secondary to TBI.
in this multi-center trial, patients were randomly assigned to 2.5:106, 5.0××106, 10×106 SB623 cells or control agents in a ratio of 1:1:1:1×
the researchers assessed the safety of patients undergoing surgical treatment (N-61) and the efficacy of surgical treatment (N-61; SB623-46, control agent-15).
patients treated with SB623 showed significant improvement in The Fugl-Meyer exercise scale score as the primary endpoint of efficacy at 6 months, and patients treated with SB623 improved at 6 months compared to the control group levels (LS Average (SE)) plus 8.3 (1.4) vs. At 2.3 (2.5), the average difference in LS is 6.0 (95% CI: 0.3-11.8) ;p -0.040.
the secondary efficacy endpoint was better than the baseline, but there was no statistical difference compared to the control group at 6 months.
toxicity or death without dose limits, and 100% of patients treated with SB623 experienced treatment emergencies, compared with 93.3% of patients in the control group (p-0.25).
It can be seen that SB623 cell implantation treatment is safer and has good tolerance, and compared with the control group, patients with chronic motor dysfunction secondary to brain trauma (TBI) implantation SB623 treatment improved significantly at 6 months.