Safety study of LR-PRP administration in low back pain patients with Modic type 1 change

Safety study of LR-PRP administration for intervertebral disc in low back pain patients with Modic type 1 change

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTb042210159

Enrollment

Registered

2022-03-14

Start date

2022-03-14

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

Disc degenerative lumbar spondylosis with Modic type 1 change

Interventions

LR-PRP extracted from autologous blood is administered into the intervertebral disc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1 Has participated in the Informed Consent process and is willing and able to sign an informed consent 2 aged 20 to 70 years old 3 Visual Analogue Scale (VAS) pain intensity 50mm or more for more than 3 months due to low back pain caused by intervertebral disc degeneration 4 Intervertebral disc degeneration with Modic type 1 change 5 Willing and able to complete scheduled follow-up evaluations as described in the study protocol

Exclusion criteria

Exclusion criteria: 1 BMI (Body Mass Index) : 30 or more 2 Has a blood dyscrasia (platelet (Plt) less than 50,000 /microliter) 3 Using anticoagulant or antiplatelet drug 4 Has an autoimmune disease 5 Has an active systemic inflammatory disease or infection 6 Has a polyarthralgia 7 Has an other spinal disease, including vertebral fracture 8 Has a compromised host status (diabetic, immune deficiency, chronic renal failure, hepatic cirrhosis, using immunosuppressive drug etc.) 9 Under treatment for malignant tumor 10 Is known to be pregnant 11 Judged as inappropriate subject by surgeons performing regenerative medicine

Design outcomes

Primary

Measure	Time frame
Incidence of adverse event at each study visit 1 Blood testing 2 Finding on X-ray image 3 Other findings	—

Secondary

Measure	Time frame
Changes at each study visit from pretreatment state on all other outcomes Blood testing Pain VAS ODI RDQ Disc height on plain radiograph Pfirrmann classification of intervertebral discs on MRI Signal change of the vertebral body end plate on MRI Area of high signal region on sagittal T2 image of MRI Number of utilization and dosage of analgesics Correlation between patient factors and improvement of symptom	—

Measure

Time frame

Changes at each study visit from pretreatment state on all other outcomes Blood testing Pain VAS ODI RDQ Disc height on plain radiograph Pfirrmann classification of intervertebral discs on MRI Signal change of the vertebral body end plate on MRI Area of high signal region on sagittal T2 image of MRI Number of utilization and dosage of analgesics Correlation between patient factors and improvement of symptom

—

Countries

Japan

Contacts

Public ContactShuji Umemura

Fujita Health University

kenshien@fujita-hu.ac.jp+81-562-93-2862

Outcome results

None listed

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