Individual Patient Expanded Access IND Using HB-adMSCs for the Treatment of Chronic Musculoskeletal Pain.
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 试验地点
- 1
研究概览
简要总结
This is an Individual Patient Expanded Access IND providing multiple administrations of HBadMSCs for the treatment of Chronic Musculoskeletal Pain. The study duration is approximately 32 weeks, during that time the study subject will complete 1 screening visit, 6 infusion visits, one follow-up visit without infusion and one end of study visit. Next day telephone follow-up visits will occur following each infusion. Efficacy and safety labs as well as quality of life and VAS scores will be obtained.
详细描述
Visit 1 - Screening During the screening visit, the principal investigator and/or delegated staff must provide a copy of the IRB-approved informed consent form * to the subject before performing any study procedure.
* IRB must provide a certificate action as proof of approval of the informed consent form.
The study subject should take enough time to read this essential document. If the study subject agrees to participate in the clinical trial, after reading the document, he/she must sign it. By giving his/her signature, study subject allows the principal investigator and/or designated staff to perform the following study procedures:
- Collection of Medical History.
- Collection of prior (up to a week before screening) and current medications.
- Evaluation of Inclusion and Exclusion Criteria.
- Measurement of Weight in lb. and Height in cm.
- Collection of vital signs, including respiratory rate, pulse rate SPO2, blood pressure and body temperature.
- Collection of laboratory samples, including Comprehensive Metabolic Panel, Complete Blood Count and Coagulation Panel, C - reactive protein and Erythrocyte sedimentation rate.
- Physical Examination by the principal investigator.
- Video documentation of the subject walking and expressing the level of pain he/she presents at that visit.
Visits 2, 3, 4, 6 and 7. (Infusions 1, 2, 3, 5 and 6) Throughout these visits, the principal investigator and/or delegated staff will perform the following assessments:
研究设计
- 研究类型
- Expanded Access
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
- •Subject is > 18 years of age at the time of signing the informed consent form.
- •Subject has the diagnosis of chronic musculoskeletal pain for a least 1 year or VAS score > 7 a screening visit.
- •Subject has provided informed consent before initiation of any study procedure.
- •Subject and sexual partner if woman of childbearing potential must use a least 1 highly effective form of birth control* throughout the study and for 6 months after the last dose of the investigational product.
排除标准
- •Subject has any active infection for which antibiotics were indicated within 4 weeks before screening.
- •Subject has known alcoholic addiction or dependency, uses alcohol daily, or has current substance use or abuse.
- •Subject has any active malignancy, including evidence of cutaneous basal, squamous cell carcinoma, or melanoma.
- •Subject has 1 or more significant concurrent medical conditions per investigator judgment, including the following:
- •poorly controlled diabetes.
- •chronic kidney disease
- •heart failure
- •myocardial infarction or unstable angina within 6 months prior to screening.
- •uncontrolled hypertension
- •Subject has received any stem cell treatment within 12 months before first dose of investigational product.
- •Subject has laboratory abnormalities during screening, including the following:
- •White blood cell count < 3000/mm3
- •Platelet count < 125,000mm3
- •Absolute neutrophil count < 1500/mm3
- •Subject has any other laboratory abnormality, which, in the opinion of the investigator poses a safety risk or will prevent the subject for completing the study.
- •Subject is currently receiving treatment in another investigational drug study.
- •Subject is unlikely to complete the study or adhere to the study procedures.