Individual Patient Expanded Access IND to Evaluate the Safety and Preliminary Efficacy of Autologous HB-adMSCS for the Treatment of Bilateral Knee 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 of autologous adipose derived Mesenchymal Stem Cells with the primary goal of treating 1 individual with bilateral knee pain who has exhausted all treatment options, his condition has not improved, and his quality of life is severely affected by the condition. There are no FDA approved, fully restorative treatments for his condition. The subject will receive 2 autologous HB-adMSCs intravenous infusion of 200 million (2 x 10^8 cells) total cells, and 4 autologous HB-adMSCs intra-articular injections (1 in each knee joint/ intervention).
详细描述
- Screening Visit Week 0 The subject will go through a screening process that will last up to 14 days. During this time the Clinical Investigator will review labs and diagnostic test results to confirm study eligibility. Abnormal test results (i.e., ongoing infection), may require follow-up before proceeding with the treatment. This screening period will start with the "Screening Visit", which will include the following procedures:
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Informed Consent will be obtained.
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Demographics
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Review of inclusion and exclusion criteria
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Review of medical history and concomitant medications
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Physical exam
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Vital signs (Heart Rate, Blood Pressure, Respirations, Temp., SpO2)
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Height and weight
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Blood samples will be collected for safety assessments:
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Hematology
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Chemistry
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Coagulation Panel
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A verification of patient consent will be verbally performed.
- Intervention 1 Day 1 (Week 1) and Intervention 2 Day 1 (Week 12) Once the eligibility is confirmed, +7 days after the screening visit, the subject will return to
HBSCRF to receive the IV treatment. Procedures will be assessed as follows:
- Review of medical history, adverse events, and concomitant medications.
- Physical exam
- Patient pain assessment VAS of Pain
- Patient pain assessment WOMAC Knee Score
- Vital signs (Heart Rate, Blood Pressure, Respirations, Temp., SpO2)
- Weight measurement
- A verification of patient consent will be verbally performed
- The HB-adMSCs will be administered and the patient closely observed:
研究设计
- 研究类型
- Expanded Access
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
