Table 1.
Completed clinical trials on stem cell research in ischemic stroke patients in the clinicaltrials.gov database.
| Year | Title | Study Design | Objectives | Number of Enrolled Patients | Condition | Stem Cell Type | Route of Administration/Delivery | Time after Stroke | Follow-up Period | Primary Outcome Measures | Clinical Trial Identification Number |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2015–2017 | Intraarterial Stem Cells in Subacute Ischemic Stroke [79] | Phase 1; interventional; prospective randomized end observer blinded study; test group (stem cell therapy) vs. control group (standard of care) | Evaluation of the safety of intervention | 229 (18–80 years old) | Acute MCA ischemic stroke | Autologous BMMNC stem cells | Intraarterial: Ipsilateral MCA | 0–15 days | 6 months | - Change in NIHSS - Symptomatic intracranial hemorrhage - New ischemic lesion - Death |
NCT03080571 |
| 2009–2011 | Stem Cell Therapy for Acute Ischemic Stroke Patients [80] | Phase 2; interventional; prospective randomized end observer blinded study; test group (stem cell therapy) vs. control group (standard of care) | Evaluation of the efficacy of intervention | 120 (18–70 years old) | MCA/ACA ischemic stroke | Autologous BMSCs | Intravenous | 7–29 days | 6 months | Functional ability to perform activities of daily living on MBI score | NCT02425670 |
| 2014–2017 | A Phase II Efficacy Study of Intracerebral CTX0E03 DP in Patients with Stable Paresis of the Arm Following an Ischemic Stroke [81] | Phase 2; interventional; prospective randomized efficacy study; non-comparative study | Evaluation of the efficacy of intervention | 23 (≥40 years old) | MCA ischemic stroke; arm paresis | Allogenic human neural stem cell (CTX DP) | Intracerebral | >28 days | 12 months | A minimum of 2 points of improvement in the ARAT test number 2 | NCT02117635 |
| 2014–2017 | Reparative Therapy in Acute Ischemic Stroke with Allogenic Mesenchymal Stem Cells from Adipose Tissue, Safety Assessment, a Randomized, Double-Blind Placebo-Controlled Single-Center Pilot Clinical Trial (AMASCIS-01) [82] | Phase 2; interventional; prospective randomized double-blind, efficacy study; test group (stem cell therapy) vs. control group (placebo) | Evaluation of the efficacy of intervention | 19 (60–80 years old) | Ischemic stroke | Allogenic MSC from adipose tissue | Intravenous | 12 h | 24 months | - Serious adverse events - Neurological and systemic complications - Development of tumors. |
NCT01678534 |
| 2008–2011 | Intravenous Autologous Bone Marrow-Derived Stem Cells Therapy for Patients with Acute Ischemic Stroke [83] | Phase 2; interventional; prospective randomized double-blind, safety, feasibility and efficacy study; test group (stem cell therapy) vs. control group (placebo) | Evaluation of the safety, feasibility and efficacy of intervention | 120 (18–70 years old) | Acute ischemic stroke | Autologous BMSCs | Intravenous | 7–30 days | 6 months | Difference between the two groups in MBI score | NCT01501773 |
| 2011–2015 | Study to Examine the Effects of MultiStem in Ischemic Stroke (MASTERS) [84] | Phase 2; interventional; prospective randomized double-blind, safety and effectiveness study; test group (stem cell therapy) vs. control group (placebo) | Evaluation of the safety and potential effectiveness of intervention | 134 (18–83 years old) | Ischemic stroke | Adult stem cell investigational product, MultiStem (BMSCs, allogenic) | Intravenous | 1–2 days | 7 days 90 days 365 days |
- Frequency of dose-limiting adverse events - Stroke recovery |
NCT01436487 |
| 2011–2015 | A Phase 1/2A Study of the Safety and Efficacy of Modified Stromal Cells (SB623) in Patients with Stable Ischemic Stroke [85] | Phase 1, phase 2; interventional; safety and efficacy study; single group assignment | Evaluation of the safety and potential effectiveness of intervention | 18 (18–75 years old) | Chronic, stable ischemic stroke patients | Modified stem cells, SB623 | Stereotactic surgical implantation | 6–60 months | 2 years | Safety (WHO criteria); Improvement in stroke symptoms | NCT01287936 |
| 2009–2010 | Efficacy Study of CD34 Stem Cell in Chronic Stroke Patients [86] | Phase 2; interventional; prospective randomized double-blind, safety and effectiveness study; test group (stem cell therapy) vs. control group (conventional treatment) | Evaluation of the safety and efficacy of intervention | 30 (35–70 years old) | MCA ischemic stroke | Autologous peripheral blood stem cell (CD34+) | Intracerebral | 6–60 months | 1,2,4,12 weeks, 6,12 months | NIH-stroke scale (NIHSS) | NCT00950521 |
| 2010–2017 |
Intravenous Stem Cells After Ischemic Stroke
[87] |
Phase 2; Interventional; prospective randomized double-blind, safety and effectiveness study; test group (stem cell therapy) vs. control group (conventional treatment) | Evaluation of the safety and efficacy of intervention | 31 (18–70 years old) | Ischemic stroke | Autologous MSCs | Intravenous | 14 days | 2 weeks, 1,2,4,6 months; 1,2 years | Feasibility and tolerance of the intravenous injection of autologous mesenchymal stem cells in patients with carotid ischemic stroke | NCT00875654 |
| 2008–2011 | Autologous Bone Marrow Stem Cells in Middle Cerebral Artery Acute Stroke Treatment [88] | Phase 1, phase 2 trial. Interventional; prospective. | Evaluation of the safety and efficacy of intervention | 20 (18–80 years) | MCA * ischemic stroke | Autologous CD34+ BMSCs | Intraarterial—in the MCA * | 5–9 days | 1,3,6 months | Absence of new neurological deficits and adverse effects during the timeframe | NCT00761982 |
| 2007–2012 | A Phase I/II Safety and Tolerability Study Following the Autologous Infusion of Immuno-selected CD34+ Subset Bone Marrow Stem Cells into Patients with Acute Total Anterior Circulation Ischemic Stroke [89] | Phase 1, phase 2 trial. Interventional; prospective; non-randomized; single group study; safety and tolerability study. | Evaluation of the safety and tolerability of intervention | 5 (30–80 years old) | Total or partial anterior circulation syndrome; acute ischemic stroke | Autologous CD34+ BMSCs | Intraarterial—in the ipsilateral MCA * | 7 days | 6 months | Adverse events graded according to CTC toxicity criteria and laboratory test results | NCT00535197 |
| 2005–2011 | Study of Autologous Stem Cell Transplantation for Patients with Ischemic Stroke [90] | Phase 1, phase 2 trial. Interventional; prospective; non-randomized; single group study; safety and feasibility study | Evaluation of the safety and feasibility of intervention | 12 (18–75 years old) | MCA * ischemic stroke | Autologous BMSCs | Intraarterial Intravenous |
3 h to 90 days | 4 months | Absence of new neurological deficits during the procedure and at follow-up | NCT00473057 |
* MCA—middle cerebral artery; ACA—Anterior cerebral artery; NIHSS—National Institutes of Health Stroke Scale; BMMNC—Bone marrow-derived mononuclear cell; BMSCs—Bone marrow-derived stem cells; MBI—Modified Barthel Index; MSC—mesenchymal stem cells.