The Department of Neural Regenerative Medicine, Tokyo Rosai Hospital
New Treatment Option for Spinal Cord Injury: Stemirac®
In September 2022, the Department of Neural Regenerative Medicine at Tokyo Rosai Hospital began using Stemilac® (generic name: human autologous bone marrow-derived mesenchymal stem cells) for the treatment of acute spinal cord injuries, marking the first administration of this therapy in the Kanto region of Japan. Our goal is to mitigate the long-term effects of spinal cord injuries, such as motor paralysis, sensory disturbances, and autonomic nervous system disorders.
Stemilac® is a regenerative medicine product created by cultivating mesenchymal stem cells from the patient’s own bone marrow, where these cells make up about 0.1% of the bone marrow fluid. The patient’s serum is used in the culture solution, which helps grow these stem cells. Over 2 to 3 weeks, the cells are expanded approximately 10,000-fold, reaching around 100 million units. After undergoing rigorous safety and quality testing, the product is ready for use.
The treatment involves a 60-minute peripheral vein infusion. Stemilac® is used alongside conventional spinal cord injury treatments, including rehabilitation therapy. Our experienced rehabilitation therapists utilize the latest equipment and techniques, and we collaborate closely with recovery-phase rehabilitation hospitals.
Stemilac® is covered by standard medical insurance, and patients may also be eligible for the High-Cost Medical Expense Benefit under Japan’s healthcare system.
Regarding transportation to our hospital: For patients within the Kanto area, our ambulance service may be available for transport. For those traveling from farther away, we can arrange ambulance transport from Haneda Airport or Shinagawa/Tokyo Station. If you are interested in receiving this treatment, please have your primary physician contact our Regional Coordination Office by phone or fax.
How to Request Treatment
Our department provides comprehensive treatment for spinal cord injuries, from the acute stage of systemic management and rehabilitation to the chronic stage of reintegration into society. We do not accept direct applications for treatment from patients or their families, so please ensure that a referral is requested from the attending physician at the medical institution where the patient is hospitalized. If you are an attending physician who wishes to refer a patient, please download the medical information form (PDF or Excel format) from the link below and send it by email or fax to the address provided.
Please send the form to the Department of Neurology and Transplantation at Tokyo Rosai Hospital.
FAX: 03(3744)9310
E-mail:
Please note that we will not respond to emails from anyone other than medical institutions or medical doctors.
Medical Information Form (PDF)
Medical Information Form (Excel)
Adapted Diseases and Eligibility Criteria
Adapted Disease:
Traumatic spinal cord injury with an ASIA Impairment Scale classification of A, B, or C (severe)
Eligibility Criteria:
Bone marrow fluid collection within 31 days of spinal cord injury:
Note: To prepare for culture, the patient must be transferred to our hospital within two weeks of the injury.Exclusion Criteria:
-
- History of hypersensitivity to any components of this product
- Current or past malignant tumors
- Allergy predisposition
- Infectious diseases
- Low body weight (especially in children) and anemia
- Very poor general health (e.g., endocrine metabolic disease, cardiovascular disease, respiratory disease, gastrointestinal disease, severe multiple traumas, multi-organ dysfunction, etc.)
- Severe intracranial lesions, significant stenosis of major blood vessels, dissecting aortic aneurysm, severe arteriosclerosis, severe calcification, etc.
- Severe spinal cord/vertebral conditions (e.g., osteoporosis, spinal cord tumors, spinal cord vascular malformations, spinal cord cavitation, etc.)
- Uncontrolled blood pressure (systolic pressure over 140 mmHg or diastolic pressure over 90 mmHg)
- Any other conditions deemed inappropriate by the attending physician
Achievements
We have received referrals from across Japan and have administered Stemilac® to a wide range of patients, from their teens to their 70s.
Number of patients treated with Stemilac Injection at our hospital as of May 2024
| Administered | 27 |
|---|---|
| Discontinued | 3 |
| Currently in culture | 3 |
| Total | 33 |
The reasons for discontinuation were infection in one case and cancer in two cases.
*Please note that Stemilac® can only be administered to patients who meet specific conditions. Even if administration of Stemilac® is requested, it may not always be possible.
Staff
| Name | Ai Namioka |
|---|---|
| Title | Deputy Chief, Department of Neural Regenerative Medicine Deputy Chief, Department of Rehabilitation |
| Education | Graduated from Kitasato University School of Medicine in 2004 Graduated from Department of Neuro Regenerative Medicine, Graduate School of Medicine, Sapporo Medical University in 2018 |
| Certifying physician | Board Certification in Regenerative Medicine, Japanese Society for Regenerative Medicine, Japan Medical Association Certified Industrial Physician |
| Medical Specialist | Specialist at the Japan Stroke Society, Japanese Neurosurgery Specialist, Specialist of the Japan Society of Neurovascular Therapeutic Society, Rehabilitation Department Specialist |
| Others | Designated physician under Article 15 of the Act on the Welfare of Persons with Disabilities |
| Name | Takahiro Namioka |
|---|---|
| Title |
Deputy Director, Department of Neural Regenerative Medicine
Deputy Director, Department of Rehabilitation |
| Education | Graduated from Kitasato University School of Medicine in 2004 Graduated from Department of Neuroregenerative Medicine, Graduate School of Medicine, Sapporo Medical University in 2018 |
| Certifying physician |
Board Certification in Regenerative Medicine, Japanese Society for Regenerative Medicine, Japan Medical Association Certified Industrial Physician |
| Medical Specialist |
Specialist at the Japan Stroke Society, Japanese Neurosurgery Specialist, Rehabilitation Department Specialist |
| Others | Designated physician under Article 15 of the Act on the Welfare of Persons with Disabilities |
June 1, 2023