A Study to Evaluate Allogenic Bone-Marrow Mesenchymal Stromal Cell Product StromaForte in Aging Frailty Patients

Launched by CELLCOLABS CLINICAL SPV LIMITED · Sep 29, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment called StromaForte, which is made from special cells derived from human bone marrow. The goal is to see if this treatment is safe for older adults who are experiencing frailty, a condition that can make them weaker and less active. The study will include 12 men and women aged 60 to 85 who meet specific criteria, such as having a certain level of frailty and being able to walk a certain distance.

Participants in this study can expect to receive StromaForte through an intravenous (IV) infusion and will be carefully monitored for any side effects. To be eligible, individuals must be able to give consent, have a mild to moderate level of frailty, and meet other health criteria. However, those with certain medical conditions, like serious neurological disorders or uncontrolled diabetes, will not be allowed to participate. This trial is currently recruiting participants, and it aims to help researchers better understand how this treatment may benefit older adults dealing with frailty.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Willing and able to provide written informed consent and comply with all procedures required by the protocol
• • Aged ≥ 60 and ≤ 85 years at the time of signing the informed consent form,
• • Have a Canadian Study on Health and Aging (CSHA) Clinical Frailty Scale score of 5 "mildly frail" or 6 "moderately frail"
• • Have a 6-minute walk distance of \> 200m and \< 400 m
• • Have a serum TNF-alpha level ≥2.5 pg/ml
• Exclusion Criteria:
• • Unwilling or unable to perform any of the assessments required by the protocol
• • Have a diagnosis of any disabling neurologic disorder, including, but not limited to, Parkinson's disease, Amyotrophic Lateral Sclerosis, multiple sclerosis, cerebrovascular accident with residual deficits (e.g., muscle weakness or gait disorder), or diagnosis of dementia
• • Have a score of 24 or lower on the Mini Mental State Examination (MMSE)
• • Have poorly controlled blood glucose levels (HbA1c \>8.0%)
• • Have a clinical history of malignancy within 2.5 years (i.e., patients with prior malignancy must be cancer free for 2.5 years) except curatively treated basal cell carcinoma, melanoma in situ or cervical carcinoma
• • Have any condition that limits lifespan to \< 1 year according to the Principal Investigator discretion
• • Have autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus)
• • Undergoes chronic immunosuppressant therapy such as high-dose corticosteroids or TNF-α antagonists (prednisone use at doses of \< 5 mg daily is allowed)
• • Hepatitis B virus positive
• • Viraemic Hepatitis C virus, HIV-1/2 or syphilis positive
• • Have a resting blood oxygen saturation of \<93% (measured by pulse oximetry)
• • Known or suspected alcohol or drug abuse within three years preceding Screening
• • Have a known hypersensitivity to dimethyl sulfoxide (DMSO)
• • An organ transplant recipient (other than transplantation for corneal)
• • Actively listed (or expected future listing) for transplant of any organ (other than corneal transplant)
• • Have any clinically important abnormal screening laboratory values, including, but not limited to: i. Haemoglobin \<10.0 g/dL, ii. White blood cell \<2,500/ul, or platelet count \<100,000/ul iii. Liver dysfunction evidenced by enzymes (AST and ALT) \> 3 times the upper limit of normal (ULN)
• • Coagulopathy with international normalized ratio (INR) \>1.3 not due to a reversible cause (e.g., warfarin and/or Factor Xa inhibitors)
• • Uncontrolled hypertension (resting systolic blood pressure \>180 mm Hg or diastolic blood pressure of \> 110 mm Hg at Screening)
• • Have unstable angina pectoris, uncontrolled or severe peripheral artery disease within the previous 3 months
• • Have congestive heart failure defined by New York Heart Association (NYHA) Class III or IV, or an ejection fraction of \<25
• • Have a coronary artery bypass surgery, angioplasty, or peripheral vascular disease revascularization or a myocardial infarction within previous 3 months
• • Have severe pulmonary dysfunction: acute exacerbation of chronic obstructive lung disease stage III or IV (Gold classification), and/or PaO2 levels \<60 mmHg
• • Have a partial ileal gastric bypass, or other significant intestinal malabsorption
• • Have advanced liver or renal disease
• • Have cognitive or language barriers that prohibit obtaining informed consent or any study elements
• • (or participated within the previous 30 days of consent) in an investigational Currently hospitalized or living in an assisted living facility or a long-term care facility
• • Currently participating therapeutic or device trial
• • Have a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the patient's participation for the full duration of the study