臨床研究等提出・公開システム

An Observational Study of Changes in Neurological Symptoms and Functional Impairments in Patients Receiving Gait Training Using the HAL Lower Limb Type for Self-Support and Related Devices, Following Treatment with Autologous Bone Marrow-Derived Mesenchymal Stem Cells (Stemirac inj.) (SHINE Study)

Stemirac and HAL for Integrated Neurorehabilitation and Enhancement (SHINE Study) (SHINE Study)

Nakajima Takashi

NHO Niigata National Hospital

3-52 Akasakacho Kashiwazaki city

nakajima-md@mqb.biglobe.ne.jp

Nakajima Takashi

NHO Niigata National Hospital

3-52 Akasakacho Kashiwazaki city

+81-257-30-8806

225-kenkyuu@mail.hosp.go.jp

Pending

May. 18, 2026

Observational

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1) Patients capable of providing written informed consent. If a study participant has sufficient capacity to consent but is unable to write due to paralysis or other reasons, written consent shall be obtained by a proxy in the presence of a witness after confirming that the participant agrees to participate in the study.
2) Patients with spinal cord injury who are 18 years of age or older at the time informed consent is obtained.
3) Patients who have received an injection of autologous bone marrow-derived mesenchymal stem cells (Stemirac) for traumatic spinal cord injury.
4) Patients with a WISCI II score of 2 or higher and 19 or lower.
5) Patients who, due to gait impairment caused by traumatic spinal cord injury, are unable to walk 10 meters independently and safely but are able to walk 10 meters or more with assistance or using a walking aid.
6) Patients capable of participating in approximately 30-40 minutes of walking exercise therapy.
7) Patients capable of wearing the HAL Lower Limb Type for Independence Support (Size 2S: weight 15-50 kg, height 100-150 cm; Size S or larger: weight 40-100 kg, height 150-190 cm). However, even if a patient's height falls outside this range, the patient may still be eligible if their body measurements (such as thigh length, lower leg length, and hip width) are compatible.

1) Patients with medical conditions or injuries other than traumatic spinal cord injury that affect walking function.
2) Patients with medical conditions or diseases that require restrictions on walking training.
3) Patients who are unable to have HAL bioelectrodes applied due to skin conditions or other reasons.
4) Patients who, while wearing the HAL Lower Limb Type for Independence Support, are unable to perform assisted hip or knee joint movements in CVC mode, or in whom the ground reaction force sensors do not function.
5) Patients who have participated in other studies or similar research within the 3 months prior to registration.
6) Patients deemed unsuitable for participation in this study by the principal investigator or a co-investigator.

Both

Patients with traumatic spinal cord injury following administration of Stemirac

HAL, cybernics treatment, Stemirac, spinal cord injury

Spinal Cord Injuries, MeSH Unique ID: D013119

Change in distance on the 2-minute walk test (2MWT) six months after the baseline assessment

Changes observed from baseline to subsequent assessments and the final assessment for the following outcome measures.
1. 2-minute walk test (2MWT), excluding assessments corresponding to the primary outcome measures
2. 10-meter walk test (speed, step length, cadence)
3. ISNCSCI score (including the ASIA Functional Scale)
4. WISCI II
5. FIM
6. SCIM-III
7. Baseline assessment of the Japanese version of the DRS

+81-257-22-2126

Mar. 27, 2026

No

none