Status:
RECRUITING
A Study of Human Allogeneic Bone-marrow Derived Mesenchymal Stromal Cell Product (StromaForte) in Patients With Musculoskeletal Injuries and/or Degeneration
Lead Sponsor:
Cellcolabs Clinical LTD.
Conditions:
Musculoskeletal Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The goal of this ongoing open-label, single-arm, phase I/IIa study in patients is designed to assess the safety of human allogeneic BM-derived MSCs product StromaForte for musculoskeletal injury or/an...
Detailed Description
Musculoskeletal disorders (MSDs) and injuries represent a significant global health concern, constituting the primary cause of disability on a global scale. With a high prevalence spanning various sta...
Eligibility Criteria
Inclusion
- Willing and able to provide written informed consent and comply with all procedures required by the protocol.
- Aged ≥ 18 years at the time of signing the informed consent form and has any diagnosed musculoskeletal injury and/or degenerative conditions.
Exclusion
- Unwilling or unable to perform any of the assessments required by the protocol.
- Have an injury that is expected to selfheal within 14 days without remaining sequel.
- Have an injury for which there is solid scientific evidence that the study compound will have no effect.
- Have traumatic head injury or skull, teeth or jaw injury as diagnosis for inclusion in trial.
- Have an injury that require an orthopaedic surgery that has not been addressed by local/home surgeon.
- Have end stage liver or renal disease.
- 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's discretion.
- Hepatitis B virus positive
- Viraemic Hepatitis C virus, HIV-1/2 or syphilis positive
- Have unstable angina pectoris, uncontrolled or severe peripheral artery disease within the previous 2 months.
- Have congestive heart failure defined by New York Heart Association (NYHA) Class IV, or an ejection fraction of \<25%.
- Uncontrolled hypertension (resting systolic blood pressure \>220 mm Hg or diastolic blood pressure of \> 150 mm Hg at screening) .
- Have coronary artery bypass surgery, angioplasty, peripheral vascular disease revascularization, or a myocardial infarction within the previous month.
- Have acute exacerbation of chronic obstructive lung disease stage III or IV (Gold classification), Have cognitive or language barriers that prohibit obtaining informed consent or any study elements.
- Severe acute infection at time of screening and treatment with study drug
- Pregnant or Breastfeeding
- Currently participating (or participated within the previous 30 days of consent) in an investigational 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 :
October 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 19 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06074783
Start Date
October 20 2023
End Date
October 19 2028
Last Update
April 19 2024
Active Locations (1)
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1
Live Well
Nassau, The Bahamas, The Bahamas