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Verification of safety of intravenous administration of autologous adipose-derived neural progenitor stem cells for neuropathic pain.

Verification of safety of intravenous administration of autologous adipose-derived neural progenitor stem cells for neuropathic pain.

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTb070250113
Enrollment
10
Registered
2025-12-12
Start date
2025-12-12
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuropathic Pain

Interventions

Intravenous administration of autologous adipose tissue-derived neural progenitor stem cells

Sponsors

Sakaguchi Hisashi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Individuals diagnosed with neuropathic pain (2) Individuals whose symptoms have not improved with oral medication (3) Individuals between the ages of 20 and 80 (4) Individuals who have provided written informed consent (5) Individuals who are able to participate in safety evaluation tests and related procedures

Exclusion criteria

Exclusion criteria: (1) Individuals with an allergy to anesthetics used during fat collection (2) Individuals undergoing dialysis (3) Individuals who are pregnant (4) Individuals who are currently hospitalized (5) Individuals deemed by the principal investigator to have abnormal vital signs or blood test results (e.g., liver or kidney function) outside the normal range (6) Individuals who test positive for infectious disease screening (HBs antigen, HCV antigen/antibody, HIV antigen/antibody, HTLV-1 antigen/antibody, and syphilis (7) Individuals with sepsis or suspected sepsis (8) Those with a history of malignant tumors

Design outcomes

Primary

MeasureTime frame
Chest X-ray Medical interview (physical examination) This test is performed 2 to 3 hours after intravenous administration of autologous adipose-derived neural progenitor cells to confirm that no adverse events caused by the administration of specific cell products have occurred.

Secondary

MeasureTime frame
Medical Examination and Interview Height and weight, treatment history, comorbidities, medical history, physical findings, body temperature, blood pressure, pulse, oxygen saturation, pain intensity (VAS, NRS, FRS),etc. Blood Tests General hematological tests including red blood cells, white blood cells, and platelets, and biochemical tests including liver and kidney function Imaging tests: chest X-ray, electrocardiogram(ECG) The above will be performed before administration and after the first intravenous administration (4 weeks, 8 weeks, 12 weeks,16 weeks, 20weeks) to confirm that no adverse events caused by the administration of specific cell products have occurred.

Countries

Japan

Contacts

Public ContactYayoi Ando

Kougekai Medical Corporation

main@reborn-clinic.com+81-92-707-6310

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026