Intravenous Autologous Bone Marrow Mononuclear Stem Cell Therapy for Ischemic Stroke: A Multicentric, Randomized Trial
Abstract
Background and Purpose—: Pilot studies have suggested benefit from intravenous administration of bone marrow mononuclear stem cells (BMSCs) in stroke. We explored the efficacy and safety of autologous BMSCs in subacute ischemic stroke. Methods—: This was a phase II, multicenter, parallel group, randomized trial with blinded outcome assessment that included 120 patients. Patients with subacute ischemic stroke were randomly assigned to the arm that received intravenous infusion of autologous BMSCs or to control arm. Coprimary clinical efficacy outcomes were Barthel Index score and modified Rankin scale at day 180. Secondary outcomes were change in infarct volume, National Institute of Health Stroke Scale (NIHSS) at day 90 and 180. Main safety outcomes were adverse events, any new area of 18 fluorodeoxyglucose positron emission tomography uptake in any body part over 365 days. Results—: Fifty-eight patients received a mean of 280.75 million BMSCs at median of 18.5 days after stroke onset. There was no significant difference between BMSCs arm and control arm in the Barthel Index score (63.1 versus 63.6; P =0.92), modified Rankin scale shift analysis ( P =0.53) or score >3 (47.5% versus 49.2%; P =0.85), NIHSS score (6.3 versus 7.0; P =0.53), change in infarct volume (−11.1 versus −7.36; P =0.63) at day 180. Adverse events were also similar in the 2 arms, and no patient showed any new area of 18 fluorodeoxyglucose uptake. Conclusions—: With the methods used, results of this hitherto first randomized controlled trial indicate that intravenous infusion of BMSCs is safe, but there is no beneficial effect of treatment on stroke outcome. Clinical Trial Registration—: URLs: http://ctri.nic.in/Clinicaltrials and http://www.clinicaltrials.gov . Unique identifiers: CTRI-ROVCTRI/2008/091/0004 and NCT0150177.
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MSC transplantation for acute stroke improves patient symptoms and promotes neurological recovery in ischemic stroke patients without adverse effects.
“MSC transplantation for acute stroke improves patient symptoms and promotes neurological recovery in ischemic stroke patients without adverse effects.360–362”
From Inflammation and aging: signaling pathways and intervention therapies (2023) · cites this paper as [360]
The Discussion concludes that bone marrow mononuclear stem cell therapy was safe but ineffective for moderately severe subacute ischemic stroke. The Abstract reports no significant improvement in functional or neurological outcomes versus controls. Adverse events were comparable between groups, not absent. (LLM, conf=0.94)
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Inflammation and aging: signaling pathways and intervention therapies
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- Authors
- Prasad, K., Sharma, A., Garg, A., Mohanty, S., Bhatnagar, S., Johri, S., Singh, K. K., Nair, V., Sarkar, R. S., Gorthi, S. P., Hassan, K. M., Prabhakar, S., Marwaha, N., Khandelwal, N., Misra, U. K., Kalita, J., & Nityanand, S.
- Affiliations
- Sanjay Gandhi Post Graduate Institute of Medical Sciences (IN)
- ORCID
- Venue
- Stroke
- Published
- 2014-12
- Volume
- 45
- Issue
- 12
- Pages
- 3618-3624
- ISSN
- 0039-2499 (ISSN-L)
- 1524-4628
- OpenAlex
- W1993845966
- Cited by
- 307
- References
- 18
- Citations by year
- 2026: 10 · 2025: 21 · 2024: 21 · 2023: 23 · 2022: 13 · 2021: 31 · 2020: 42 · 2019: 23 · 2018: 33 · 2017: 42 · 2016: 37 · 2015: 11
- FWCI
- 15.00
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Stroke (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Genetics › Mesenchymal stem cell research
- Health Sciences › Medicine › Epidemiology › Acute Ischemic Stroke Management
- Health Sciences › Medicine › Rehabilitation › Stroke Rehabilitation and Recovery
- Keywords
- ischemic stroke, subacute stroke, stroke outcome, functional recovery, infarct size, safety, adverse events, 18F-fluorodeoxyglucose uptake
- MeSH terms
- Aged, Female, Humans, Magnetic Resonance Imaging, Male, Middle Aged, Bone Marrow Transplantation, Hematopoietic Stem Cell Transplantation, Recovery of Function, Stroke
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