Asterias Biotherapeutics Inc, in an update regarding its ongoing SCiStar Phase 1/2a clinical trial, reports that its sixth and final patient in the study has demonstrated motor function improvements at 6 months following administration of AST-OPC1.
“We are excited to see the sixth and final patient in the AIS-A 10 million cell cohort show upper extremity motor function improvement at 3 months and further improvement at 6 months, especially because this particular patient’s hand and arm function had actually been deteriorating prior to receiving treatment with AST-OPC1,” states Dr Edward Wirth III, chief medical officer, in a media release from Asterias Biotherapeutics Inc.
“We are very encouraged by the meaningful improvements in the use of arms and hands seen in the SCiStar study to date since such gains can increase a patient’s ability to function independently following complete cervical spinal cord injuries.”
The SCiStar study is monitoring two separate International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) measurements of upper extremity motor function. The upper extremity motor score (UEMS), is a linear scale used to quantify motor function at each of five upper extremity muscle groups driving arm and hand function; these scores are also used to calculate “motor levels,” which define the level within the cord above which a subject has a certain minimum level of function.
The UEMS improvement at 6 months for the final patient was 9 points and in line with the median and average 6-month UEMS improvement for all six patients in this cohort (9.7 average; 9 median). In all six patients, administration of AST-OPC1 was followed by early improvements in UEMS at 3-months that were sustained or further increased through their most recent follow-up assessment.
In addition to the motor score gains, the final patient in the AIS-A 10 million cell cohort has so far achieved a one motor level improvement over baseline on both sides of his body. All six patients in this cohort have now achieved at least a one motor level improvement over baseline on at least one side, the release explains.
“These results are quite encouraging, and suggest that there are meaningful improvements in the recovery of functional ability in patients treated with the 10 million cell dose of AST-OPC1 versus spontaneous recovery rates observed in a closely matched untreated patient population,” says Asterias Chief Executive Officer Steve Cartt, in the release. “We look forward to reporting additional efficacy and safety data for this cohort, as well as for the currently enrolling AIS-A 20 million cell and AIS-B 10 million cell cohorts, later this year.”
[Source(s): Asterias Biotherapeutics Inc, PR Newswire]