This article requires a subscription to view the full text. If you have a subscription you may use the login form below to view the article. Access to this article can also be purchased.
Abstract
Objective To test whether autologous modified mesenchymal stem cells (MSCs) improve recovery in patients with chronic major stroke.
Methods In this prospective, open-label, randomized controlled trial with blinded outcome evaluation, patients with severe middle cerebral artery territory infarct within 90 days of symptom onset were assigned, in a 2:1 ratio, to receive preconditioned autologous MSC injections (MSC group) or standard treatment alone (control group). The primary outcome was the score on the modified Rankin Scale (mRS) at 3 months. The secondary outcome was to further demonstrate motor recovery.
Results A total of 39 and 15 patients were included in the MSC and control groups, respectively, for the final intention-to-treat analysis. Mean age of patients was 68 (range 28–83) years, and mean interval between stroke onset to randomization was 20.2 (range 5–89) days. Baseline characteristics were not different between groups. There was no significant difference between the groups in the mRS score shift at 3 months (p = 0.732). However, secondary analyses showed significant improvements in lower extremity motor function in the MSC group compared to the control group (change in the leg score of the Motricity Index, p = 0.023), which was notable among patients with low predicted recovery potential. There were no serious treatment-related adverse events.
Conclusions IV application of preconditioned, autologous MSCs with autologous serum was feasible and safe in patients with chronic major stroke. MSC treatment was not associated with improvements in the 3-month mRS score, but we did observe leg motor improvement in detailed functional analyses.
Classification of Evidence This study provides Class III evidence that autologous MSCs do not improve 90-day outcomes in patients with chronic stroke.
ClinicalTrials.gov Identifier NCT01716481.
Glossary
- BBB=
- blood-brain barrier;
- CI=
- confidence interval;
- CST=
- corticospinal tract;
- DTI=
- diffusion tensor imaging;
- FAC=
- Functional Ambulatory Category;
- FBS=
- fetal bovine serum;
- FMA=
- Fugl-Meyer Assessment;
- FMA-LL=
- FMA lower limb;
- FMA-T=
- FMA total;
- FMA-UL=
- FMA upper limb;
- ITT=
- intention-to-treat;
- MEP=
- motor evoked potential;
- MI=
- Motricity Index;
- mRS=
- modified Rankin Scale;
- MSC=
- mesenchymal stem cell;
- NIIHSS=
- NIH Stroke Scale;
- STARTING=
- Stem Cell Application Researches and Trials in Neurology
Footnotes
Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
STARTING-2 coinvestigators are listed in appendix 2 at the end of the article.
Editorial, page 301
Class of Evidence: NPub.org/coe
- Received January 17, 2020.
- Accepted in final form October 8, 2020.
- © 2021 American Academy of Neurology
AAN Members
We have changed the login procedure to improve access between AAN.com and the Neurology journals. If you are experiencing issues, please log out of AAN.com and clear history and cookies. (For instructions by browser, please click the instruction pages below). After clearing, choose preferred Journal and select login for AAN Members. You will be redirected to a login page where you can log in with your AAN ID number and password. When you are returned to the Journal, your name should appear at the top right of the page.
AAN Non-Member Subscribers
Purchase access
Disputes & Debates: Rapid online correspondence
NOTE: All authors' disclosures must be entered and current in our database before comments can be posted. Enter and update disclosures at http://submit.neurology.org. Exception: replies to comments concerning an article you originally authored do not require updated disclosures.
- Stay timely. Submit only on articles published within the last 8 weeks.
- Do not be redundant. Read any comments already posted on the article prior to submission.
- 200 words maximum.
- 5 references maximum. Reference 1 must be the article on which you are commenting.
- 5 authors maximum. Exception: replies can include all original authors of the article.
- Submitted comments are subject to editing and editor review prior to posting.