Long COVID: Cord Tissue-Derived Mesenchymal Stromal Cells for Persistent NeuroInflammatory Symptoms
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- Charles Cox
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Determine the safety and establish the maximum tolerated dose (MTD) of allogenic human cord tissue derived MSCs (hCTMSCs) as determined by infusional toxicity of the cell product.
研究概览
简要总结
The purpose of this research study is to test the safety and benefit of a human cord blood derived stem cell infusion as a treatment for individuals with post COVID-19 neurological problems. Participants in the study will have 6 clinic visits over a 12 to 14 mo. period with each visit lasting 2 to 6 hours. Participants will receive 1 stem cell infusion at study visit #3. Participants will have a brain PET and MRI scan at the baseline and 6mo. post-infusion visits. Follow-up safety assessments will be conducted at 6mo. and 1yr. after the stem cell infusion.
详细描述
This is a non-randomized, Phase 1/2a dose escalation study using allogenic cord tissue MSC's in adults with chronic neurological symptoms following an acute COVID-19 infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults between 18 and 55 years of age.
- •Documented history of COVID-19 infection with resulting neurological sequela.
- •Post-Covid-19 Functional Status score of grades 3 or
- •Chronic neurological symptoms defined as anxiety/depression, pain syndromes, sleep disorders, and /or memory disorders ("brain fog") persisting 6 months after an acute COVID-19 infection.
- •Ability to obtain consent from the subject.
- •Ability to communicate in English or Spanish (required for validated neurocognitive outcome testing).
排除标准
- •Known history of:
- •intellectual deficiency or psychiatric conditions likely to invalidate our ability to assess changes in cognition or behavior,
- •recently treated infection,
- •renal disease or altered renal function (screening serum creatinine > 1.5 mg/dL),
- •hepatic disease or altered liver function (screening SGPT > 150 U/L and/or T. Bilirubin >1.3 mg/dL),
- •immunosuppression (screening WBC < 3, 000 cells/ml),
- •chemical or ETOH dependency that in the opinion of the investigator would preclude participation in the study,
- •acute or chronic lung disease requiring significant medication/oxygen supplementation,
- •bleeding disorders including immune-mediated heparin-induced thrombocytopenia,
- •hypercoagulable disorders (Protein C, S, ATIII deficiencies), Factor V Leiden,
- •known sensitivity to heparin, Lovenox, and pork products,
- •individuals with mechanical prosthetic heart valves.
- •Pulse oximetry oxygen saturation <93% on room air.
- •Other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation.
- •For women of childbearing potential, a positive pregnancy test at the screening visit or, for both women and men, unwillingness to comply with acceptable methods of birth control during the study.
- •Previous or concurrent participation in an interventional drug or biological study.
- •Inability to undergo the diagnostic tests (PET/DT-MRI) or unwilling/unable to cooperate with the diagnostic tests and outcome assessments.
- •Unwilling or unable to return for follow-up study visits.
- •Prisoner/Incarcerated.
结局指标
主要结局
Determine the safety and establish the maximum tolerated dose (MTD) of allogenic human cord tissue derived MSCs (hCTMSCs) as determined by infusional toxicity of the cell product.
时间窗: Assessed for the first 24 hours after each stem cell infusion.
Physical Exam
次要结局
- Investigate if the hCTMSC infusions reduce the neuroinflammatory response following an acute COVID-19 infection as measured by the degree of microglial activation.(Baseline visit to 6 months post-infusion.)
研究者
Charles Cox
The George and Cynthia Mitchell Distinguished Chair in Neurosciences Director, Children's Program in Regenerative Medicine Professor, Departments of Surgery and Pediatric Surgery UTHealth, McGovern Medical School at Houston
The University of Texas Health Science Center, Houston