Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 5
- 主要终点
- C Reactive Protein
研究概览
简要总结
This is a Pilot Study which is randomized, prospective, open label, dose escalation, non-controlled evaluating safety and feasibility of intra-articular Wharton's Jelly (WJ) allograft will be evaluated in patients suffering with knee osteoarthritis. The participants will be randomized to one of three dosing treatment arms that will consist of one intra-articular knee injection containing either low dose, medium dose or high dose WJ allograft tissue.
详细描述
This is a Pilot Study which is randomized, prospective, open label, dose escalation, non-controlled study in which the safety and feasibility of intra-articular Wharton's Jelly (WJ) allograft will be evaluated in patients suffering with knee OA. The participants will be randomized to one of three dosing treatment arms that will consist of one intra-articular knee injection containing either low dose, medium dose or high dose WJ allograft tissue.
As this is a Pilot Study primarily designed to evaluate safety, no control will be used. The dosing groups will consist of either 2cc WJ Allograft (Low Dose), 3cc WJ Allograft (Medium Dose), or 4cc WJ Allograft (High Dose) with 120 total patients randomized into the three arms equally. In addition to baseline outcome instruments along with imaging and laboratory studies, patients will be followed for one year for evaluation of safety, pain relief and functional improvements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
With double blinding of the allograft neither participant nor provider will know what is being administered.
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be over age 30
- •Diagnosed with Grade II or III OA on the KL scale (in one knee).
- •Body Mass Index (BMI) <50Kg/m2
- •Pain score of 4 or more on the Numeric Pain Rating Scale (NPRS)
- •Female patients must be abstinent, surgically sterilized or postmenopausal
- •Premenopausal females must have a negative pregnancy test, on contraceptive measures and do not anticipate pregnancy during the duration of the study.
- •Be willing and capable of giving written informed consent to participate in English.
- •Be willing and capable of complying with study-related requirements, procedures and visits in English.
排除标准
- •Have taken any pain medication including nonsteroidal anti-inflammatory drugs (NSAIDs) within 2 weeks prior to study injection date.
- •Use anticoagulants have a substance abuse history and fail to agree not to take any knee-symptom modifying drugs during the course of the study without discussing and reporting the use to the site principal investigator and study team.
- •Have had an intra-articular injection of any drug including viscosupplementation in the index knee in the past 6 months.
- •Have had surgery on the index knee with the past 6 months.
- •Had a traumatic injury to the index knee with the past 3 months.
- •Planned elective surgery during the course of the study.
- •A history of organ or hematologic transplantation, rheumatoid arthritis, or other autoimmune disorders.
- •Be on immunosuppressive medications.
- •Have a diagnosis of carcinoma with the past 2 years.
- •Have a knee infection or have used antibiotics for knee infection within the past 3 months.
- •Have participated in any other clinical trial or treatment (not just for the knee, but for any reason) with any investigational product within the past 30 days prior to inclusion of study.
- •Female patients who are breast feeding or are pregnant or desire to become pregnant during the course of the study.
- •Contraindications to radiographic or MRI imaging.
- •Serious neurological, psychological or psychiatric disorders.
- •Injury or disability claims under current litigation or pending or approved workers compensation claims.
- •Have a known drug allergy to amphotericin-B, ciprofloxacin, gentamycin, penicillin, or streptomycin.
研究组 & 干预措施
2cc WJ Allograft (Low Dose)
The 2cc Whartons Jelly Allograft group receives an intra-articular knee injection and is considered the Low Dose Group.
干预措施: Umbilical Cord Wharton's Jelly Allograft Intra-articular Knee Injection (Biological)
3cc WJ Allograft (Medium Dose)
The 3cc Whartons Jelly Allograft group receives an intra-articular knee injection and is considered the Medium Dose Group.
干预措施: Umbilical Cord Wharton's Jelly Allograft Intra-articular Knee Injection (Biological)
4cc WJ Allograft (High Dose)
The 4cc Whartons Jelly Allograft group receives an intra-articular knee injection and is considered the High Dose Group.
干预措施: Umbilical Cord Wharton's Jelly Allograft Intra-articular Knee Injection (Biological)
结局指标
主要结局
C Reactive Protein
时间窗: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
C-reactive protein (CRP) is a protein made by the liver. The level of CRP increases when there's inflammation in the body. A simple blood test can check your C-reactive protein level. C-reactive protein is measured in milligrams per liter (mg/L). Results equal to or greater than 8 mg/L or 10 mg/L are considered high. Range values vary depending on the lab doing the test. A high test result is a sign of inflammation. It may be due to serious infection, injury or chronic disease. Your health care provider may recommend other tests to determine the cause.
Erythrocyte Sedimentation Rate
时间窗: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
Sed rate, or erythrocyte sedimentation rate (ESR), is a blood test that can show inflammatory activity in the body. Because a sed rate test can't pinpoint the problem that's causing inflammation in your body, it's often accompanied by other blood tests, such as the C-reactive protein (CRP) test. ESR is measured in millimeters per hour (mm/hr). The normal values are: 0 to 15 mm/hr in men 0 to 20 mm/hr in women
Alanine Transaminase
时间窗: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
ALT is an enzyme that converts proteins into energy for the liver cells. Aspartate transaminase (AST). AST is an enzyme that helps the body break down amino acids. Alkaline phosphatase (ALP). ALP is an enzyme important for breaking down proteins. Albumin and total protein. Albumin is a protein made in the liver. Bilirubin. Bilirubin is a substance produced during the breakdown of red blood cells. Gamma-glutamyltransferase (GGT). Higher-than-usual may mean liver damage. L-lactate dehydrogenase (LD). LD is an enzyme found in the liver. Prothrombin time (PT). PT is the time it takes your blood to clot. Standard range: Alanine transaminase (ALT). ALT is an enzyme that converts proteins into energy for the liver cells. Standard range: ALT. 7 to 55 units per liter U/L.
Aspartate Transaminase
时间窗: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
AST is an enzyme that helps the body break down amino acids. . Standard range: AST 8 to 48 units per liter
Alkaline Phosphatase
时间窗: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
ALP is an enzyme important for breaking down proteins. Standard range: 40 to 129 units per liter
Albumin
时间窗: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
Albumin is a protein made in the liver. Normal range is 34 to 54 grams/liter.
Creatinine
时间窗: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
Creatinine is a waste product that comes from the digestion of protein in your food and the normal breakdown of muscle tissue. It is removed from the blood through your kidneys. Everyone has some creatinine in their blood, but too much can be a sign of a possible kidney problem. Normal range is 0.6-1.3 milligrams/deciliter
Blood Urea Nitrogen
时间窗: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
blood urea nitrogen (BUN) test reveals important information about how well your kidneys are working. A BUN test measures the amount of urea nitrogen that's in your blood. Normal BUN is 6-20 milligrams/deciliter.
次要结局
- 36-Item Short Form Survey (SF-36)(Baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year)
- Numerical Pain Rating Scale (NPRS)(Baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year)
- Knee Injury and Osteoarthritis Outcome Score(Baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year)