Injection of Autologous Bone Marrow Aspirate in Patients With Degenerative Disc Disease: a Phase I Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Numeric Rating for Back pain at 12 months
研究概览
简要总结
Lumbar discectomy and injection of purified cellular bone marrow concentrate or lumbar discectomy only
详细描述
In order to find a regenerative treatment for back pain from DDD, cell based therapies have become of increasing interest. Recent clinical studies have shown promising improvement in pain and disc hydration, thus indicating a regenerative effect.
The use of mesenchymal stem cells for regeneration of degenerated connective tissue of mesenchymal origin has proven efficient in multiple recent studies. However, the acquisition of mesenchymal stem cells (MSC) is always an extensive procedure requiring either enzymatic or genetic manipulation of acquired tissues. Thus, the use of these MSCs is highly controversial and raises concerns in terms of patient safety.
One of the most commonly used sources for MSCs is bone marrow tissue. Even when not manipulated, these tissues already contain a significant amount of mesenchymal stem cells and growth factors. Therefore, they are used for regenerative treatments of multiple degenerative musculoskeletal diseases.
This is an exploratory pilot study which aims to compare patient outcomes between two treatments approaches for DDD that are currently being used in clinic. While micro- discectomy is the standard of care for DDD, micro-discectomies with autologous bone marrow cell injections have been used in clinic in the past year. The goal of this study is to determine if the bone marrow injection group is superior compared to the control group (state of the art micro-discectomies) in enhancing degenerative disc recovery and improving or preventing back pain.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients ≥18 years of age
- •Radiologically (MRI) confirmed diagnosis degenerative disc disease of the lumbar spine and/or lumbar disc herniation
- •Unresponsive to conservative/non-operative treatment for >3 months
- •Psychosocial, mental and physical ability to understand and to adhere to this protocol, especially adhering to the visit schedule follow-ups, and observe treatment plan
- •Signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the trial study-related procedures
排除标准
- •Pregnant or breastfeeding patients
- •Active malignancy
- •Active chronic or acute infection
- •Autoimmune disorder that impacts the lumbar spine (Ankylosing spondylitis, lupus eg.)
- •Acute Episode or major mental illness
- •Major cognitive impairment causing to inability to understand informed consent
结局指标
主要结局
Change in Numeric Rating for Back pain at 12 months
时间窗: Baseline, 3 months, 6 months, 12 months after surgery
0 to 10 NRS
次要结局
- Pfirrman grading(Baseline and 12 months or longer folllow-up after surgery)
- Complications(Continrous monitoring during study during one year after surgery)
- Disc Height Index(Baseline and 12 months or longer folllow-up after surgery)
- Change in Oswestry Disability Index at 12 months(Baseline, 3 months, 6 months, 12 months after surgery)
- Change in NRS Leg pain(Baseline, 3 months, 6 months, 12 months after surgery)
研究者
Pravesh Gadjradj
on behalf of PI: Prof.dr.R.Hartl, chief of spine surgery
New York Presbyterian Hospital