Status:
UNKNOWN
A Study to Evaluate Allogenic Bone-Marrow Mesenchymal Stromal Cell Product StromaForte in Aging Frailty Patients
Lead Sponsor:
Cellcolabs Clinical SPV Limited
Collaborating Sponsors:
PDC-CRO
Conditions:
Aging Frailty
Eligibility:
All Genders
60-85 years
Phase:
PHASE1
PHASE2
Brief 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 adv...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06063590
Start Date
November 28 2023
End Date
April 1 2025
Last Update
November 22 2023
Active Locations (1)
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1
Burjeel Medical City
Abu Dhabi, United Arab Emirates