Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-25 @ 5:24 PM
Study NCT ID:
NCT07168603
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-11
First Post:
2025-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EvaluatIon of Autologous Nucleus Pulposus Cells (aNPC) in Degenerative Disc Disease
Sponsor:
ASTEROGENE Biomedical Co. Ltd.
Organization:
Study Overview
Official Title:
A Phase I/II Clinical Trial to Evaluate Safety and Efficacy of Autologous Nucleus Pulposus Cells (aNPC) Transplantation in the Treatment of Degenerative Disc Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label, single-center Phase I/II clinical trial investigating the safety and efficacy of autologous nucleus pulposus cells (aNPC) in patients with disc degeneration. Eligible participants are those assessed by the principal investigator to have disc herniation suitable for discectomy and confirmed disc degeneration. During the treatment period, participants will receive a single injection of autologous nucleus pulposus cells at a concentration of approximately 1×10⁶ viable cells/mL with a total volume not exceeding 3 mL. The injection will be guided by C-arm X-ray to ensure accurate placement into the degenerated central nucleus pulposus of the disc from which tissue was previously harvested. Participants will be followed for 12 months. Safety assessments will primarily include monitoring for inflammatory responses using ESR and CRP after cell injection, as well as recording any treatment-emergent adverse events (AEs). Efficacy will be evaluated using pain assessment and imaging outcomes, including lumbar X-ray and MRI reviewed independently by a radiologist. Additionally, patient-reported outcomes will assess quality of life improvements following treatment using the Visual Analogue Scale (VAS), Activities of Daily Living (ADLs), and the Oswestry Disability Index (ODI). Laboratory tests, including CBC/DC, BUN, creatinine, AST, and ALT, will also be conducted throughout the treatment and observation period to monitor participant safety.
Detailed Description:
Degenerative disc disease (DDD) commonly occurs in adults and represents an irreversible aging process. It is also one of the primary causes of low-back pain (LBP). The nucleus pulposus possesses high water-retention capacity, allowing it to cushion the vertebrae and reduce friction during movement. However, with aging, the disc gradually loses its water absorption ability and becomes fibrotic, leading to structural degeneration. In addition, sports injuries or sudden mechanical stress may cause disc herniation, compressing spinal nerves and triggering both disc degeneration and back pain. The release of inflammatory mediators further induces severe pain. Once the nucleus pulposus herniates, the tissue continues to degenerate, placing greater stress on the surrounding annulus fibrosus. Over time, this accelerates the progression of DDD.
Regenerative medicine has recently emerged as a promising clinical treatment approach, aiming to restore or rebuild healthy tissue through biological means, with cell therapy being a key area of development. In our approach, autologous cells are harvested from patients' tissue, expanded and activated through ex vivo cell culture, and then reintroduced into the degenerated disc region under X-ray guidance. This autologous cell therapy avoids the risk of immune rejection or transplant-related complications. For patients undergoing treatment for disc herniation, discectomy not only relieves pain symptoms but also provides herniated disc tissue as an ideal source of autologous disc cells for further use in regenerative therapy. These cells can serve as a valuable implant material for disc repair.
The current clinical trial enrolls both male and female subjects aged ≥20 years who have not undergone prior disc surgery. Eligible patients must be diagnosed with disc herniation and scheduled for discectomy, during which nucleus pulposus tissue will be collected for cell culture. Following cell expansion, the cultured cells will be reintroduced into the degenerated disc region via injection. Subjects will undergo multiple follow-up visits within one year after surgery to evaluate safety and efficacy, supplemented with imaging studies to assess disc height, tissue regeneration, and water-retention capacity. Hence, the primary objective of this study is to evaluate the safety of aNPC during the treatment of disc degeneration. Secondary objectives include evaluating the effects of these cells on subjects' quality of life, as measured by Activities of Daily Living (ADLs) and the Oswestry Disability Index (ODI), on pain improvement assessed by the Visual Analogue Scale (VAS), and on imaging outcomes, including lumbar X-ray and MRI assessments, before and after treatment.
This clinical study will be conducted in accordance with the requirements of the Institutional Review Board (IRB) and will fully comply with Good Clinical Practice (GCP) standards and relevant regulations to minimize patient safety risks. In the future, this therapy has the potential to reduce the long-term reliance on pain medications, avoid associated side effects, slow disc degeneration, and alleviate pain and discomfort. Furthermore, it is expected to decrease the need for surgical interventions and provide a more effective and convenient therapeutic option for patients suffering from degenerative disc disease.
Regenerative medicine has recently emerged as a promising clinical treatment approach, aiming to restore or rebuild healthy tissue through biological means, with cell therapy being a key area of development. In our approach, autologous cells are harvested from patients' tissue, expanded and activated through ex vivo cell culture, and then reintroduced into the degenerated disc region under X-ray guidance. This autologous cell therapy avoids the risk of immune rejection or transplant-related complications. For patients undergoing treatment for disc herniation, discectomy not only relieves pain symptoms but also provides herniated disc tissue as an ideal source of autologous disc cells for further use in regenerative therapy. These cells can serve as a valuable implant material for disc repair.
The current clinical trial enrolls both male and female subjects aged ≥20 years who have not undergone prior disc surgery. Eligible patients must be diagnosed with disc herniation and scheduled for discectomy, during which nucleus pulposus tissue will be collected for cell culture. Following cell expansion, the cultured cells will be reintroduced into the degenerated disc region via injection. Subjects will undergo multiple follow-up visits within one year after surgery to evaluate safety and efficacy, supplemented with imaging studies to assess disc height, tissue regeneration, and water-retention capacity. Hence, the primary objective of this study is to evaluate the safety of aNPC during the treatment of disc degeneration. Secondary objectives include evaluating the effects of these cells on subjects' quality of life, as measured by Activities of Daily Living (ADLs) and the Oswestry Disability Index (ODI), on pain improvement assessed by the Visual Analogue Scale (VAS), and on imaging outcomes, including lumbar X-ray and MRI assessments, before and after treatment.
This clinical study will be conducted in accordance with the requirements of the Institutional Review Board (IRB) and will fully comply with Good Clinical Practice (GCP) standards and relevant regulations to minimize patient safety risks. In the future, this therapy has the potential to reduce the long-term reliance on pain medications, avoid associated side effects, slow disc degeneration, and alleviate pain and discomfort. Furthermore, it is expected to decrease the need for surgical interventions and provide a more effective and convenient therapeutic option for patients suffering from degenerative disc disease.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: