Therapy with mesenchymal stem cells (MSC) with autologous serum resulted in a subtle improvement in leg motor skills, but did not change the modified Rankin scale (mRS) in patients with chronic stroke. This was the result of a prospective, open, randomized, controlled study published in Neurology.
The study researchers recruited patients (N = 54) with chronic stroke for the STARTING-2 study (ClinicalTrials.gov-ID: NCT01716481) at 4 university hospitals in South Korea. They randomly assigned patients in a 2: 1 ratio to receive intravenous MSC (n = 39) or standard care (n = 15) and evaluated them for clinical outcomes for 3 months.
Patients in the intervention and control arms of the study had a mean age of 63.03 (± 14.36) and 64.27 (± 13.25) years, 43.6% and 66.7% were men and their body mass was -Index was 23.2 (± 3.59) and 23.47 (±) 2.92) kg / m².
After 90 days, 33.3% of the patients in the treatment group and 26.7% of the patients in the control group had no decrease in the mRS values; These values did not differ significantly between the groups (P = 0.732).
No other endpoints differed significantly between groups, including changes in Fugl-Meyer score (P = 0.292), functional outpatient category (P = 0.763), or side (P = 0.090) or arm motility index (P =) . 741).
However, recipients of the MSC had an increased mean leg motility index (14.8 ± 23.8) compared to participants in the control group (2.6 ± 13.0; P = 0.023), but the observed change in score was after Adjusted for possible no longer significant cofactors (P = 0.129).
A higher percentage of patients in the MSC cohort had poor clinical results according to the Fugl-Meyer Lower Extremity Assessment, but had a good response rate according to the Predict Recovery Potential (P = 0.032) and the Predict Recovery Potential-II (P = .017) Algorithms.
In the intervention group, 1 patient had an allergic reaction and 1 had a systemic complication. In the control group, 1 patient had a recurrent stroke or a transient ischemic attack.
This study was limited due to the small sample size and open design. Since no bone marrow aspiration could be performed among the participants in the control group, the blinding was not sufficient.
These data indicated a potentially modest biological potential for the use of MSC in patients with chronic stroke. Additional studies of cultivation techniques, patient-specific biomarkers, and circulating factors are needed to more accurately assess the potential therapeutic efficacy of MSC.
Chung JW, Chang WH, Bang OY, et al .; STARTING-2 employees. Efficacy and safety of intravenous mesenchymal stem cells in ischemic stroke. Neurology. 2021; 96 (7): e1012-e1023. doi: 10.1212 / WNL.0000000000011440