A Study of Human Allogeneic Bone-marrow Derived Mesenchymal Stromal Cell Product (StromaForte) in Patients With Musculoskeletal Injuries and/or Degeneration

Launched by CELLCOLABS CLINICAL LTD. · Oct 4, 2023

Keywords

ClinConnect Summary

This clinical trial is studying 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 people with musculoskeletal injuries or degeneration, which means issues with muscles, bones, or joints. This study is currently recruiting participants who are at least 18 years old and have a diagnosed musculoskeletal injury or condition. To be eligible, participants must be able to understand the study and give their consent. However, certain health conditions, such as severe heart disease or recent cancer treatment, may prevent someone from joining the trial.

If you participate, you will receive an injection of StromaForte into the injured area of your body, and possibly an additional infusion into your bloodstream if needed. The researchers will track your safety and how pain changes over time after the treatment. It's important to know that this is an early phase study, meaning the main focus is on understanding the safety of the treatment rather than its effectiveness. If you’re considering joining, you can expect close monitoring and follow-ups to see how you respond to the treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Willing and able to provide written informed consent and comply with all procedures required by the protocol.
• • 2. Aged ≥ 18 years at the time of signing the informed consent form and has any diagnosed musculoskeletal injury and/or degenerative conditions.
• Exclusion Criteria:
• • 1. Unwilling or unable to perform any of the assessments required by the protocol.
• • 2. Have an injury that is expected to selfheal within 14 days without remaining sequel.
• • 3. Have an injury for which there is solid scientific evidence that the study compound will have no effect.
• • 4. Have traumatic head injury or skull, teeth or jaw injury as diagnosis for inclusion in trial.
• • 5. Have an injury that require an orthopaedic surgery that has not been addressed by local/home surgeon.
• • 6. Have end stage liver or renal disease.
• • 7. 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.
• • 8. Have any condition that limits lifespan to \< 1 year according to the Principal Investigator's discretion.
• • 9. Hepatitis B virus positive
• • 10. Viraemic Hepatitis C virus, HIV-1/2 or syphilis positive
• • 11. Have unstable angina pectoris, uncontrolled or severe peripheral artery disease within the previous 2 months.
• • 12. Have congestive heart failure defined by New York Heart Association (NYHA) Class IV, or an ejection fraction of \<25%.
• • 13. Uncontrolled hypertension (resting systolic blood pressure \>220 mm Hg or diastolic blood pressure of \> 150 mm Hg at screening) .
• • 14. Have coronary artery bypass surgery, angioplasty, peripheral vascular disease revascularization, or a myocardial infarction within the previous month.
• • 15. 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.
• • 16. Severe acute infection at time of screening and treatment with study drug
• • 17. Pregnant or Breastfeeding
• • 18. Currently participating (or participated within the previous 30 days of consent) in an investigational therapeutic or device trial.
• • 19. 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.