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| Name | Class |
|---|---|
| PDC-CRO | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSC arm | Experimental | The patients will be receiving allogeneic bone marrow (BM)-derived Mesenchymal Stromal Cell (MSC) formulated in infusion solution (sodium chloride supplemented with human serum albumin) in a low intravenous infusion of 100 millions MSCs within approximately 30 min |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| StromaForte | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | 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 | 28 days post-infusion |
| Measure | Description | Time Frame |
|---|---|---|
| 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.) | From baseline to 6 months |
| Change in C Reactive Protein (CRP) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the 6-minute walk test | Change in the 6-minute walk test (6-MWT) from baseline to 28-, 84- and 168- days post infusion. | From baseline to 6 months |
| Change in hand grip strength | Change in hand grip strength (dynamometry) from baseline to 28 ,84 and 168 days post-infusion. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fahti Yousef, PhD | Study Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burjeel Medical City | Abu Dhabi | United Arab Emirates |
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The patients will be assigned into one group receiving allogeneic bone marrow (BM)- derived Mesenchymal Stromal Cell (MSC) formulated in infusion solution (sodium chloride supplemented with human serum albumin Pre-screening visit will be conducted within 7 days of the screening visit then eligible patient will participate in the Study for approximately 6 months and will have a total of 5 on-site visits, including a screening visit, a treatment administration visit, and 3 follow-up visits.
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Change in C Reactive Protein (CRP) from baseline to 6 months (baseline to 28-, 84-, and 168-days post-infusion.)
| 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.) | 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.) | From baseline to 6 months |
| From baseline to 6 months |
| Change in EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS) | Change in EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS) from baseline to 84-, and 168-days post-infusion. The maximum score of EQ-5D is 1 which indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems. In addition, there is a visual analogue scale (VAS) to indicate the general health status with 100 indicating the best health status. | From baseline to 6 months |
| Change in Multidimensional Fatigue Inventory (MFI) | Change in Multidimensional Fatigue Inventory (MFI) from baseline to 84-, and 168-days post-infusion. MFI-20 has an even proportion of positively and negatively worded items that are rated on a 5-point Likert scale. Subscale scores (range 4-20) are calculated as the sum of item ratings and a total fatigue score (range 20-100) is calculated as the sum of subscale scores. | From baseline to 6 months |
| Change in 36-Item Short Form health survey (SF-36) | Change in 36-Item Short Form health survey (SF-36) from baseline to 84-, and 168-days post-infusion. To score the SF-36, scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain a score ranging from 0 to 100. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales. | From baseline to 6 months |
| Change in the MMSE | Change in the Mini Mental State Examination (MMSE) criteria after 6 months. The maximum score for the MMSE is 30. A score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment. | From baseline to 6 months |