A Study to Evaluate Allogenic Bone-Marrow Mesenchymal Stromal Cell Product StromaForte in Aging F… (NCT06063590) | Clinical Trial Compass
CompletedPhase 1/2
A Study to Evaluate Allogenic Bone-Marrow Mesenchymal Stromal Cell Product StromaForte in Aging Frailty Patients
United Arab Emirates12 participantsStarted 2024-01-22
Plain-language summary
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.
Who can participate
Age range60 Years – 85 Years
SexALL
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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 al…