This phase I/IIa study in frail patients is designed to assess the safety of intravenous human allogenic bone marrow-derived mesenchymal stromal cell product StromaForte by reporting the number of adverse events assessed by Common Terminology Criteria. 12 male and female patients aged 60 to 85 years will be enrolled.
Frailty is theoretically defined as a clinically recognizable state of increased vulnerability resulting from aging-associated decline in reserve and function across multiple physiologic systems such that the ability to cope with every day or acute stressors is comprised. In the absence of a gold standard, frailty has been operationally defined by Fried et al. as meeting three out of five phenotypic criteria indicating compromised energetics: low grip strength, low energy, slowed waking speed, low physical activity, and/or unintentional weight loss. One major factor proposed to contribute to frailty and related epigenetic dysregulation is stem cell loss. In order to treat this multifactorial dysregulation, stem cell therapy is an interesting strategy, and MSCs are a particularly tempting candidate. MSCs are an immune-privileged somatic progenitor cell type that is multipotent, self-renewing, and relatively simple to harvest (bone marrow harvest), isolate, and grow. MSCs are proven to regulate the body's immune response in many diseases and exert anti-inflammatory effects. Following their discovery over 50 years ago, mesenchymal stromal cells (MSCs) have become one of the most studied cellular therapeutic products by both academia and industry due to their regenerative potential and immunomodulatory properties. The promise of MSCs as a therapeutic modality has been demonstrated in a number of preclinical studies as well as in clinical setting. Stromaforte cells which will be used in this study is developed within CELLCOLABS AB which is a parent company to Cellcolabs Clinical SPV Limited and were generated following the same protocol established over the last 20 years by scientists CELLCOLABS AB at the Karolinska Institute in Sweden. Currently completed in vivo studies on rats, rabbits and mice models showed that MSCs could attenuate sarcopenia via increasing skeletal muscle weight and myofiber cross-sectional area. The physical performance including muscle strength as well as endurance were significantly enhanced. In addition, MSCs have capability to activate resident skeletal muscle stem cells, which lead to myogenesis and differentiation of muscle tissues. The positive results provide novel insights into sarcopenia intervention, suggesting a potential role for MSC therapy in aging frailty. This study which has been designed to evaluate the safety of intravenous human allogenic bone marrow-derived mesenchymal stromal cell product StromaForte in frail patients before further clinical development.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
100 millions allogeneic bone marrow (BM)-derived Mesenchymal Stromal Cell (MSC) formulated in sodium chloride supplemented with human serum albumin to be given via slow intravenous infusion in approximately 30 min
Burjeel Medical City
Abu Dhabi, United Arab Emirates
RECRUITINGSafety
To assess the safety and tolerability after 28 days of injection by reporting the number of adverse events assessed by Common Terminology Criteria For Adverse Events (CTCAE) which is the Incidence of any treatment-emergent serious adverse events (TE-SAEs), defined as the composite of death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities determined per the Investigator's judgment along with others Adverse Events and Serious Adverse events
Time frame: 28 days post-infusion
Change in TNF-alpha
Change in tumor necrosis factor α TNF-α from baseline to 6 months (baseline to 28-, 84-, and 168-days post-infusion.)
Time frame: From baseline to 6 months
Change in C Reactive Protein (CRP)
Change in C Reactive Protein (CRP) from baseline to 6 months (baseline to 28-, 84-, and 168-days post-infusion.)
Time frame: From baseline to 6 months
Change in Interleukin-6 (IL-6)
Change in Interleukin-6 (IL-6) from baseline to 6 months (baseline to 28-, 84-, and 168-days post-infusion.)
Time frame: From baseline to 6 months
Change in Complete Blood Count (CBC) in peripheral blood with differential
Change in Complete Blood Count (CBC) in peripheral blood with differential from baseline to 6 months (baseline to 28-, 84-, and 168-days post-infusion.)
Time frame: From baseline to 6 months
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