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

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

Shiroki Ryoichi

April. 26, 2023

10

The average age was 53.3 years (SD=8.7), average BMI was 22.3 kg/m2 (SD=3.0), average duration of symptoms was 12.1 years (SD=10.7), consisting of 4 males and 6 females. None of the patients had comorbidities.

Ten patients who provided written informed consent were enrolled in this study, and LR-PRP was administered to the disc between May 11, 2022 and November 30, 2022. In one case, the postoperative 1week FU was not possible due to family member living with the patient was infected with COVID-19. There were no other cases in which the scheduled postoperative evaluation could not be completed.

Two Adverse Events were reported. Those events were non-serious and solved over time. Other than that, there is no AE.

1) Primary endpoint One Adverse Event (worsening of pre-existing low back pain) was reported. X-ray image and blood tests revealed no no adverse findings. 2) Secondary endpoint There were no significant changes in blood test, intervertebral disc height, Pfirrmann classification at the pretreatment and at each FU. The average VAS, which was 70.0 (SD=13.3) at pretreatment, significantly decreased at 1 week after treatment, and was 39.0 (SD=28.8) at 24 weeks after treatment(P=0.008). The average ODI, which was 41.8 (SD=11.9) at pretreatment, decreased at 1 week after treatment, and was 26.2 (SD=17.8) at 24 weeks after treatment (P=0.039). The average RDQ, which was 12.5 (SD=4.3) at pretreatment, decreased at 1 week after treatment, and was 7.2 (SD=5.5) at 24 weeks after treatment (P=0.047). The average T2* value at petreatment was 4.47 (SD=0.64), and at 24 weeks after treatment it was 4.30 (SD=0.67), which was a decreasing trend. The average high-signal intensity on fat-suppressed T2WI was 10.07mm2 (SD=5.73) at pretreatment and was 7.89mm2 (SD=5.01) at 24 weeks after treatment, which was significantly decreased (P=0.047). One patient took a drug that was prohibited in this study due to COVID-19 infection. Significant improvement in VAS (P=0.005) and ODI (P=0.025) was observed in patients with higher PLT counts on pretreatment blood tests.

The safety and efficacy of LR-PRP administration for intervertebral disc in low back pain patients with Modic type 1 change were confirmed. Postop MRI suggested improvement in inflammation, speculating that PRP suppressed inflammation and consequently relieved the patient's symptoms. This treatment is potentially promising for low back pain patients with Modic Type 1 change.

April. 02, 2024

Jan. 05, 2023

https://www.mdpi.com/1648-9144/59/1/112

https://jrct.mhlw.go.jp/latest-detail/jRCTb042210159

Fujita Noboyuki

Fujita Health University

1-98,Dengakugakubo,Kutsukake-cho,Toyoake,Aichi,470-1192

nfujita@fujita-hu..ac.jp

Umemura Shuji

Fujita Health University

1-98,Dengakugakubo,Kutsukake-cho,Toyoake,Aichi,470-1192

+81-562-93-2862

kenshien@fujita-hu.ac.jp

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

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

Both

Disc degenerative lumbar spondylosis with Modic type 1 change

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

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

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

Complete

+81-562-93-2862

Jan. 04, 2022