Use of Autologous Stem/Stromal Cellular Stromal Vascular Fraction (cSVF) In Cases Of Frailty and Aging Processes Using Autologous Stem-Stromal Cell Infusion in Patients With Aging Frailty And Wellness
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
With increasing age and health issues associated with aging, many systemic cellular and structural changes are known to occur. The intent of this trial is to determine the safety and efficacy of delivery of autologous cellular stromal vascular fraction (cSVF) to improve the quality of life and functional health.
Isolation and concentration of cSVF will be documented.
To acquire autologous cSVF, a 10+ teaspoon volume of subdermal adipose (fat) tissue and stroma is removed from the trunk or upper thigh area. Using a closed system with enzymatic digestion to isolate and concentrate these cells, is followed with returning these cSVF elements only via 500 cc Normal Saline delivered via peripheral vein (IV).
Documentation of cellular numbers and flow cytometer viability testing is to be correlated with clinical outcomes as reported by patients and standardized Quality of Life (QoL) form tracking
详细描述
With increasing age and health issues associated with aging, many systemic cellular and structural changes are known to occur. The intent of this trial is to determine the safety and efficacy of delivery of autologous cellular stromal vascular fraction (cSVF) to improve the quality of life and functional health.
Isolation and concentration of cSVF will be documented.
To acquire autologous cSVF, a 10+ teaspoon volume of subdermal adipose (fat) tissue and stroma is removed from the trunk or upper thigh area. Using a closed system with enzymatic digestion to isolate and concentrate these cells, is followed with returning these cSVF elements only via 500 cc Normal Saline delivered via peripheral vein (IV).
Documentation of cellular numbers and flow cytometer viability testing is to be correlated with clinical outcomes as reported by patients and standardized Quality of Life (QoL) form tracking.
Safety of use of certain allogeneic human mesenchymal stem cells (hMSC) has been tested and established along with the effectiveness of use. Autologous stem-stromal cells have been proven safe and effective in many applications and in clinical trials currently underway. These cells are easily obtained and isolated/concentrated in a closed system from patient's adipose derived stromal vascular fraction (cSVF). This is important as such tissues are uniquely the patient's cells, without the need for culture expansion of non-self human tissues, therefore potentially increasing availability to obtain non-allergenic, autologous cells known to be multipotent (can form a variety of specialized cell populations from the body) cell group within the cellular stromal vascular fraction (cSVF) present in essentially all tissues throughout the body (muscle, brain, bone, cartilage, nerve, skin, cardiac muscle, etc.).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be >40 and <90 years of age and willing and able to provide written informed consent
- •Those aging and frail patients who have noted compromise to activities or work requirements due to increasing age
- •Ability to execute a 6 minute walk test distance of >200 meters and <1000 meters
- •Loss of energy and exercise tolerance over 6 month period minimum
- •Current clinical history of malignancy within 3 years, except for curable skin lesions including basal cell carcinoma, or squamous cell carcinoma
- •Must have the ability to provide Informed Consent
排除标准
- •Medical conditions which prevent the ability of assessment of walk distance testing criteria
- •Have disabling neurodegenerative disorder which would impede interpretation of outcomes
- •Have a score of <24 on the Mini Mental State Examination (MMSE)
- •History of malignancy within 2 years (excluding curative skin lesion of basal cell carcinoma, melanoma-in-situ, or cervical carcinoma
- •Have clinically important abnormal screening laboratory values, including, but not limited to: Hemoglobin <10 g/dL; White blood cell count (WBC) <2500/mL; Platelet count microliters <100000/uL(microliters); Genetic Coagulopathy history
- •Uncontrollable hypertension
- •Systemic disorders that preclude completion of the testing or out of medical management control in the opinion of the PIs or Primary Care Provider
- •Expected lifespan of less that 6 months
- •Current drug abuse history < 6 months
- •Alcohol abuse within 6 months of enrollment
- •Serious or life threatening co-morbidities that in the opinion of investigators, may compromise the safety or compliance with the study guidelines and tracking.
研究组 & 干预措施
Lipoaspiration
Closed microcannula harvesting of small volume of subdermal adipose tissue, including the stromal cellular and stromal tissue using sterile, disposable, microcannula system
干预措施: Microcannula harvest adipose stromal tissues (Procedure)
Isolation & Concentration of cSVF
Isolation and Concentration of cellular stromal vascular fraction (cSVF) using a Healeon Medical CentriCyte 1000 centrifuge, incubator and shaker plate with sterile Liberase enzyme (Roche Medical) per manufacturer protocols
干预措施: Centricyte 1000 (Device)
Isolation & Concentration of cSVF
Isolation and Concentration of cellular stromal vascular fraction (cSVF) using a Healeon Medical CentriCyte 1000 centrifuge, incubator and shaker plate with sterile Liberase enzyme (Roche Medical) per manufacturer protocols
干预措施: Liberase (Drug)
Delivery cSVF via Intravenous
cSVF from Arm 2 is suspended in a 500cc of sterile Normal Saline and deployed through 150 micron in-line filtration and intravenous route over 30-60 minute time frame.
干预措施: Sterile Normal Saline IV Deployment of cSVF (Procedure)
Delivery cSVF via Intravenous
cSVF from Arm 2 is suspended in a 500cc of sterile Normal Saline and deployed through 150 micron in-line filtration and intravenous route over 30-60 minute time frame.
干预措施: Saline Solution (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: 6 months
Number of Participants with Treatment Related Adverse \& Severe Adverse Events Assessed By CTCAE v4.0
次要结局
- Fatigue(baseline and 6 months)
- Changes in Weight In Pounds(Baseline and 6 months)
- Mobility(baseline and 6 months)
- Activity Level(baseline and 6 months)
- Mobility Performance Battery(baseline and 6 months)
研究者
Robert W. Alexander, MD, FICS
Principal Investigator
Healeon Medical Inc