Lumbar disc degeneration
Conditions
Interventions
Study Group (Phase I):1.0×10^7 cells/disc, 2.0×10^7 cells/disc, and 5.0×10^7 cells/disc, with a single intradiscal injection of FibroCell-001. The administration will follow a "3+3" dose-escalation de
Control Group (Phase I):Only observation
Study Group-Dosage 1 (Phase II):Based on the safety and efficacy data obtained from the Phase I study, the high-dose level was selected as the recommended dose for Phase II.
Study Group-Dosage 2 (Phase II):Based on the safety and efficacy data obtained from the Phase I study, the low dose level was selected as the recommended dose for Phase II.
Control Group (Phase II):Saline injection
Sponsors
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Age
25 Years to 75 Years
Inclusion criteria
Inclusion criteria: Participants must meet all of the following criteria to be eligible for this study: 1.Understands and voluntarily signs the Informed Consent Form (ICF); 2.Age 25 to 75 (inclusive); 3.Body Mass Index (BMI) is calculated as 18.5-28 kg/m^2 (including the cutoff value); 4.Lumbar disc degeneration (imaging evidence) with low back pain for more than six months; 5.Persistent lower back pain for at least 3 months despite non-surgical interventions (including health education, self-management, physical therapy, exercise therapy, and medication); or if the subject has previously used opioids for at least 1 month with continued pain. 6.The visual analog scale (VAS) pain score during screening should be >= 40 mm and =1.5×10^9/L;blood cells (PLT)>=100×10^9/L;hemoglobin (Hb)>=90 g/L; Liver function:Total bilirubin (TBIL)<=1.5×ULN;Alanine aminotransferase (ALT)<=3.0×ULN;Aspartate aminotransferase (AST)<=3.0×ULN; Renal function:creatinine (Cr) <=1.5×ULN; Coagulation function:International normalized ratio (INR)<=1.5×ULN; 9.There are no contraindications for intervertebral disc injection, including but not limited to intervertebral disc infection; 10.Female subjects of childbearing age and all male subjects must promise to use effective contraceptive measures from the date of signing the informed consent to one year after the cell injection and not to allow the freezing of eggs or sperm for the purpose of reproduction.
Exclusion criteria
Exclusion criteria: Participants who meet any of the following criteria are not eligible for this study: 1.MRI imaging reveals isolated disc fragments, facet joint cysts, or moderate to severe spinal stenosis in the target segment. 2.MRI image showing Modic III changes 3.Within one year before the study treatment, the target intervertebral disc had undergone interventional surgery such as nucleus pulposus removal, intradisk electric heat therapy, intradisk radiofrequency therapy, etc.; 4.Within 6 months before the study treatment, the adjacent intervertebral disc has undergone surgery (such as nucleus pulposus removal, intradisk electrothermal therapy, intradisk radiofrequency therapy, artificial disc replacement, intervertebral fusion, etc.); 5.Patients scheduled for any spinal surgery within one year of signing the informed consent form; 6.The target or adjacent intervertebral disc has not yet healed, or the vertebral body of the target or adjacent intervertebral disc is damaged due to current or past trauma, and has clinical significance; 7.Having a neurological condition that may affect the assessment of the efficacy (e.g., chronic radiculopathy or neuropathy); 8.Patients with sacroiliac joint symptoms that may affect the evaluation of efficacy; 9.Spondyloarthropathy secondary to other diseases and involving target intervertebral discs, such as ankylosing spondylitis, rheumatoid arthritis, rheumatoid immune osteoarthropathy, etc.; 10.Have a clear inflammatory spinal pain; 11.Subjects with hemorrhagic disease (endogenous or exogenous) or who are taking anticoagulants (e.g., antiplatelet agents or anticoagulants) and who are judged by the investigator to have a bleeding risk that cannot be excluded; 12.Intradiscal glucocorticoid injection was performed on the target disc; 13.The following drug injections were performed on the target intervertebral disc within 4 weeks before the study treatment:Contrast agent (intervertebral disc contrast or other diagnostic injection);Nonsteroidal anti-inflammatory drugs (NSAIDs);Neuroblocating anesthetics (e.g., lidocaine, bupivacaine);antibiotic;normal saline; 14.Has received any indication of cellular or gene therapy; 15.Exclusion criteria include participants who received analgesic treatment within the first two weeks (or 5-6 half-lives, whichever is longer) prior to the study, with the exception of topical analgesics applied outside the study site. 16.Screening for those who have received any TCM treatment (such as acupuncture, massage, etc.) or physiotherapy in the previous week; 17.Screen for those who had used systemic immunosuppressants within the first three months; 18.Viral serological tests: positive for hepatitis B surface antigen (HBsAg) and hepatitis B DNA (HBV-DNA); or positive for hepatitis C virus antibodies (HCV-Ab) or hepatitis C virus RNA (HCV-RNA); or positive for human immunodeficiency virus (HIV); or positive for Treponema pallidum antibodies. 19.Patients with a history of drug use, alcohol abuse (defined as consuming 14 units of alcohol per week—equivalent to 285 mL of beer, 25 mL of spirits, or 100 mL of wine) or substance abuse within one year prior to signing the informed consent form. 20.Filter visits with severe systemic diseases requiring treatment. Systemic diseases include, but are not limited to, pulmonary insufficiency (COPD, pneumonia, pulmonary fibrosis, and asthma), cardiovascular and cerebrovascular diseases, etc. 21.Those who have had severe food or drug allergies in the past, or a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events and serious adverse (Phase I);VAS pain scale score (Phase II);Oswestry Disability Index score (Phase II);Lumbar CT (phase I and II); | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS pain scale score (phase I and II);SF-36 Score (phase I and II);ODI Score (phase I and II);Lumbar JOA score (only phase I);Lumbar MRI (phase I and II);Lumbar X-Ray (phase I and II);ADA (phase I and II);Inflammation-related indicators:CRP, cytokines, ESR (phase I and II);Rescue medication (only phase II);Incidence of adverse events and serious adverse (Phase II);Vital signs:Any clinically significant abnormalities in physical examination, vital signs, electrocardiogram and laboratory tests (Phase II); | — |
Countries
China
Contacts
Public ContactZhao Jie
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Outcome results
None listed