NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2031210516

Registered date:26/12/2021

Phase I/IIa Clinical Trial of KTP-001 in Subjects with Lumbar Disc Herniation

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedHerniated lumbar disc
Date of first enrollment17/01/2022
Target sample size23
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Inject 2.0mL of KTP-001 injection into the intervertebral disc

Outcome(s)

Primary OutcomeAdverse event vital signs 12-lead ECG Clinical examination MRI image X-ray image Anti-KTP-001 antibody
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 60age old
GenderBoth
Include criteria1) Patients diagnosed with L3-L4, L4-L5, or L5-S1 high posterior longitudinal ligament prolapsed lumbar disc herniated disk by clinical symptoms, neurological findings, and MRI (L3 in the case of sacral vertebralization) -L4, L4-S1, L4-L5, L5-L6, L6-S1 in the case of lumbarization Patients diagnosed with elevated posterior longitudinal subligament prolapse type lumbar disc herniated disk) 2) Patients with a positive lower limb elevation test or femoral nerve extension test that is neurologically consistent with the elevated disc of lumbar herniated disk 3) Patients with an average leg pain score / day of 4 or more for at least 3 days out of the 5 days immediately before administration and an average leg pain score / day of 2 or more for all 5 days immediately before administration ("0: Pain" Using the 11-step Numeric Rating Scale (NRS) from "None" to "10: No more pain (the strongest pain I have ever experienced)") 4) Patients with a leg pain score (NRS) of 4 or higher immediately before administration (Day 1) 5) Adult males or females aged 20 to 60 years (at the time of consent) 6) BMI is 18-35 kg / m2 7) It has been confirmed by the investigator (sharing) that no clinical problems are found based on the medical history, electrocardiogram, and physical findings. 8) Oswestry Disability Index (ODI) is 30% or more 9) Patients whose preoperative X-ray findings confirmed that the end plate of the vertebral body was closed and no growth plate was observed. 10) Patients who have received sufficient explanation using explanatory documents, understood the contents, and obtained written consent to participate in the clinical trial based on their free will.
Exclude criteria1) Based on clinical symptoms, neurological findings and MRI, a bulging herniated disk (Protrusion), a posterior longitudinal ligament penetrating herniated disk (Transligamentous extrusion), a prolapsed free lumbar herniated disk (Sequestration), and an intradural hernia were diagnosed patient 2) Patients diagnosed with intraforaminal or extraforaminal hernia by MRI 3) MRI showed significant disc herniated disk in two or more places, and it is possible that the intervertebral discs involved in clinical symptoms could not be identified from clinical symptoms and physical findings, or that multiple intervertebral disc hernias were involved. Patients determined to have 4) Patients who have undergone intervertebral disc intervention treatment or low back pain surgery in the past for herniated discs that are the subject of this study. 5) Patients who have participated in chemical karyolysis or clinical trials using drugs for intervertebral discs in the past, regardless of the height of the intervertebral disc. 6) Patients with the following lumbar spine diseases or deformities other than lumbar disc herniated disk i) Lumbar spondylolisthesis, lumbar spinal stenosis, spinal kyphosis, lumbar spinal canal stenosis not caused by lumbar herniated disk herniated disk ii) Lumbar vertebral body fracture, tonic spondylitis, inflammatory bone disease, inflammatory disc disease, primary or metastatic malignant tumor, and other vertebral body related diseases 7) Patients with cauda equina syndrome or progressive lower limb motor paralysis 8) Patients who wish to become pregnant. Female patients who may be pregnant, breastfeeding or pregnant by a pregnancy test 9) Patients whose vital signs and laboratory test values at the time of screening correspond to Grade 2 or higher in light of the common terminology standard ver. 5.0 for adverse events (CTCAE ver. 5.0). 10) Patients who are judged to be inappropriate for clinical trial participation in light of the clinical trial protocol

Related Information

Contact

Public contact
Name Hirotaka Haro
Address 1110, Shimokato, Chuo, Yamanashi Yamanashi Japan
Telephone +81-55-273-6768
E-mail haro@yamanashi.ac.jp
Affiliation University of Yamanashi
Scientific contact
Name Hirotaka Haro
Address 1110, Shimokato, Chuo, Yamanashi Yamanashi Japan
Telephone +81-55-273-6768
E-mail haro@yamanashi.ac.jp
Affiliation University of Yamanashi