Evaluating StromaForte for treating frailty in older adults

An Open-Label Single-Arm Phase I/IIa Study to Evaluate the Safety of Human Allogenic Bone-Marrow-Derived Mesenchymal Stromal Cell Product StromaForte in Patients With Aging Frailty

This study is testing a new treatment called StromaForte to see if it can help older adults aged 60 to 85 who are feeling frail and vulnerable.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 60 Years to 85 Years
• Sex: All
• Sponsor: Cellcolabs Clinical SPV Limited (Industry-sponsored)
• Drugs / interventions: prednisone
• Locations: 1 site (Abu Dhabi)
• Trial ID: NCT06063590 on ClinicalTrials.gov

What this trial studies

This phase I/IIa study aims to assess the safety of StromaForte, an allogenic bone marrow-derived mesenchymal stromal cell product, in frail patients aged 60 to 85 years. The study will enroll 12 participants and evaluate the number of adverse events using established criteria. Frailty, characterized by increased vulnerability due to aging, will be operationally defined based on specific phenotypic criteria. The intervention seeks to address stem cell loss, which may contribute to frailty, by utilizing the regenerative and immunomodulatory properties of mesenchymal stromal cells.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 60 to 85 years who are classified as mildly to moderately frail.

Not a fit: Patients with severe neurological disorders, uncontrolled diabetes, or a recent history of malignancy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve the health and resilience of frail older adults, enhancing their quality of life.

How similar studies have performed: While the use of mesenchymal stromal cells has shown promise in various preclinical and clinical settings, this specific application in aging frailty is relatively novel.

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

Where this trial is running

Abu Dhabi

• Burjeel Medical City — Abu Dhabi, United Arab Emirates (Recruiting)

Study contacts

• Principal investigator: Fahti Yousef, PhD — Study Principal Investigator
• Study coordinator: Nadir M Kadri, PhD

Conditions Aging Frailty