A Patient Sponsored Ongoing Open-label Single-arm, Safety and Efficacy, Phase I/IIb Study of Cellcolabs´ Human Allogeneic Bone-marrow Derived Mesenchymal Stromal Cell Product (StromaForte) in Patients With Musculoskeletal Injuries and/or Degeneration

2023-002-BHS

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/and degeneration. Any male or female with any musculoskeletal injury and/or degeneration above 18 years will be enrolledThe main questions it aims to answer are: To assess the safety after 28±10, 84±10, 168±10 and 349±10 days of injection by reporting the number of adverse events or severe adverse event assessed by Common Terminology Criteria Change from baseline in subjective pain assessment in each injured and/or degenerated area (if multiple injury is reported, each area to be followed up separately) Eligible patients will receive 50 x 106 allogeneic bone marrow (BM)-derived MSC formulated in 4 ml infusion solution of sodium chloride supplemented with human serum albumin to be given locally under ultrasound guidance along with or without 100 x 106 allogeneic BM-derived MSCs formulated in sodium chloride supplemented with human serum albumin to be given via slow intravenous infusion in approximately 30 min. Systemic treatment alone is used when local injection at site of injury is not feasible. Additional dose can be administered.

2023-10-20

2027-10-19

2028-10-19

Recruiting

Early phase I

30

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2024-04-19