Expanded Access Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Back Pain
试验速览
- 阶段
- 不适用
- 状态
- Available
研究概览
简要总结
CELZ-201-DDT is an investigational (experimental) cell therapy currently being studied for people with degenerative disc disease who have chronic lower back pain.
详细描述
Expanded Access to CELZ-201-DDT (Allogeneic Umbilical Cord Sub-Epithelial Cell-Derived Mesenchymal Stromal Cells) is available for individual patients with serious or life-threatening chronic lower back pain due to degenerative disc disease (DDD) who have no comparable or satisfactory alternative therapy options.
Requests will be considered on a case-by-case basis under a single-patient IND in coordination with the U.S. Food and Drug Administration (FDA) and an Institutional Review Board (IRB).
For non-emergency requests, the treating physician must submit FDA Form 3926 and obtain FDA authorization before initiating treatment.
For emergency use, treatment may begin without prior FDA authorization if criteria for emergency use are met; the physician must notify the FDA within 5 working days after treatment.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of chronic lower back pain due to degenerative disc disease.
- •No comparable or satisfactory alternative therapy available. Unable to participate in the ongoing CELZ-201-DDT clinical trial. Informed consent provided.
排除标准
- •Any medical condition that poses an unacceptable risk or would interfere with treatment safety or evaluation.
- •Known hypersensitivity to any component of the investigational product.
- •How to Request Access:
- •Contact the Expanded Access Coordinator to confirm eligibility and discuss feasibility.
- •Complete and submit FDA Form 3926 to the appropriate FDA review division.
- •Obtain IRB review (may be expedited or post-treatment for emergency use). Coordinate drug shipment and treatment schedule.