Cardiovascular and Cerebrovascular Diseases
Stem-cell approaches are not one established treatment for this disease group. In acute ischemic stroke, the 206-patient TREASURE trial did not improve the primary 90-day outcome. In Japan, RiHEART has a conditional pathway only for severe heart failure caused by ischemic cardiomyopathy after standard drug and invasive care have been insufficient. [1] [2]
We help organize medical information, compare product-specific evidence, prepare your questions, coordinate appointments and support medical translation. We don’t diagnose, prescribe or perform treatment.
Your exact diagnosis, imaging, timing and previous care determine whether published evidence is relevant.
Does your diagnosis fit the evidence?
Does the current evidence match your diagnosis?
The disease subtype and treatment stage matter more than the label “stem cell.”
Acute ischemic stroke
The largest Japan phase 2/3 randomized study of IV MultiStem did not show a significant 90-day functional benefit.
InvestigationalChronic post-stroke disability
Smaller studies have tested different cell types, routes and time windows. Results are not consistent enough to support one routine approach.
InvestigationalHemorrhagic stroke
Evidence from ischemic stroke cannot be assumed to apply after brain hemorrhage. Product- and disease-specific data are required.
InvestigationalSevere ischemic cardiomyopathy
RiHEART has conditional and time-limited approval in Japan for a narrow group after an inadequate response to standard care.
Specific Japan PathwayOther heart or vascular conditions
RiHEART data do not prove benefit for non-ischemic cardiomyopathy, stable coronary disease, peripheral vascular disease or generic IV cell infusions.
Product SpecificStart with the diagnosis, event date and latest imaging summary.
Compare with your records
Compare your records with the published patient groups.
These are study and product criteria, not a personal eligibility checklist. They show whether the outcome numbers below are reasonably comparable to your case.
Who was actually studied?
What makes the approved use narrow?
What the TREASURE trial found
The 206-patient phase 2/3 trial did not meet its efficacy goal.
TREASURE tested one IV dose of 1.2 billion allogeneic multipotent adult progenitor cells 18 to 36 hours after acute ischemic stroke at 44 sites in Japan. [1]
Three products, three outcomes
Three products. Three very different conclusions.
A cell source, delivery route and regulatory result cannot be transferred to another product.
MultiStem
Bone-marrow-derived allogeneic multipotent adult progenitor cells given intravenously. The primary 90-day efficacy endpoint was not improved in TREASURE.
HeartSheet
An autologous skeletal-myoblast cell-sheet product. PMDA found that superiority was not shown for cardiac-disease-related death: HR 1.9 (95% CI 0.8–4.4; P=.136). The HR for hospitalization due to a major cardiovascular event was 1.5 (95% CI 0.6–3.6), and core-lab LVEF improvement of at least 5% at six months was 7.9% with HeartSheet versus 16.5% in control. Full approval was not supported. [4]
RiHEART
An allogeneic iPS-cell-derived cardiomyocyte sheet placed directly on the heart surface. Japan granted a conditional, time-limited pathway with required post-market evidence collection. [2]
Approval is country-specific. [6]
How RiHEART works
It is not a generic IV stem-cell infusion.
The approved pathway is narrow and the procedure is substantial. [2]
Severe heart failure caused by ischemic cardiomyopathy after an inadequate response to standard drug and invasive treatment.
Three cardiomyocyte sheets, each containing about 33 million allogeneic iPS-derived cardiomyocytes, approximately 100 million cells in total.
The three sheets are transplanted onto the heart surface. A left thoracotomy is used in principle.
Prednisolone, tacrolimus and mycophenolate mofetil are used for 90 days, including tapering.
MHLW set this product-level reimbursement price for planned listing on September 1, 2026. The document limits reimbursement to defined use criteria and one calculation per person. This is not a generic self-pay quote or a guaranteed personal out-of-pocket amount. [3]
What the eight-patient data shows
Functional signals were observed, but the evidence base is eight patients.
The exploratory study was open-label and uncontrolled. PMDA cautioned that the small sample, concomitant care, rehabilitation and patient motivation limit efficacy conclusions. The response counts below are taken from PMDA and MHLW summaries. [2] [3]
had at least a 5% improvement in echocardiographic LVEF at week 26
had at least a one-level NYHA functional-class improvement at week 52
had at least a 10% increase in peak VO2 at week 52; one result was missing
had at least a 45-meter increase in six-minute walk distance at week 52
Recovery: what you can track
Do not accept a generic “stem-cell survival rate.”
There is no reliable personal “stem-cell survival rate” for this disease group. The available RiHEART follow-up is useful to know, but far too small to prove a survival benefit. [3]
No deaths in a five-patient or three-patient follow-up subset does not mean a 100% expected survival rate. There was no randomized comparator for RiHEART, and MHLW identifies survival and heart-failure hospitalization as outcomes that still need post-market evaluation. For stroke, TREASURE did not show an overall functional benefit at 90 or 365 days.
Don’t skip standard care
Do not delay established care while considering cell-based options.
For eligible acute ischemic stroke patients, the 2026 AHA/ASA guideline supports IV thrombolysis with alteplase or tenecteplase within the 4.5-hour treatment window and broader use of endovascular thrombectomy in selected patients. A regenerative-medicine discussion should never delay emergency assessment or reperfusion care. [5]
Possible stroke
New facial droop, one-sided weakness or numbness, speech difficulty, sudden vision loss or other sudden neurological symptoms require emergency assessment.
Possible cardiac emergency
New or severe chest pressure, fainting, marked breathlessness or rapidly worsening symptoms require emergency assessment.
What it really costs
There is no responsible single price for “stem-cell treatment.”
A price only becomes meaningful when it is tied to the exact product, route, procedure, number of administrations and follow-up plan.
Have a quote or proposal already?
Compare it against the exact product, evidence and follow-up it actually includes.
How we can help
Turn scattered records into a clearer next discussion.
We focus on information and coordination: what your diagnosis is, which evidence matches it, what questions to ask, what the quoted cost includes and what records should be ready.
Useful records: exact diagnosis and event date; discharge summary; latest brain MRI or CT report; NIHSS or mRS if available; echocardiography or cardiac imaging with LVEF; NYHA class if documented; current medicines; PCI, CABG or other major procedures; and recent rehabilitation or exercise assessments.
Put the diagnosis, timing, imaging, medicines, procedures and functional status into one usable summary.
Separate product-specific trial data from claims that come from a different cell type, route or condition.
Clarify expected endpoints, risks, required medicines, alternatives, total cost and follow-up before you decide.
Support appointment coordination and medical translation so the right questions can be discussed clearly.
What to read next
Continue with the parts that matter to your decision.
Check the sources
Check the evidence behind the numbers.
Now what?
Find out which evidence actually applies to you.
Send us the diagnosis, when the event or worsening occurred, your latest imaging or echocardiography summary, your current medications, past procedures and any cell-based option you’re already looking at. We’ll help you organize the information and questions before your next discussion.
Educational information only. Individual eligibility, risks, alternatives, prognosis and treatment decisions require assessment by a licensed physician. Evidence and regulatory status can change; confirm the exact product and current status before making a medical or financial decision.