Using stem cells to treat musculoskeletal injuries and degeneration

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This ongoing open-label, single-arm phase I/IIa study aims to evaluate the safety of StromaForte, a human allogeneic bone marrow-derived mesenchymal stromal cell product, in patients with musculoskeletal injuries and degeneration. Participants aged 18 and older will receive a local infusion of the stem cell product under ultrasound guidance. The study will monitor adverse events and changes in pain levels over several follow-up periods after treatment. The goal is to assess the potential of this innovative therapy to improve patient outcomes in musculoskeletal disorders.

Why it matters

Who can join: the full rules

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.

Where it's running

• Live Well
  Nassau, The Bahamas, The Bahamas Recruiting

Study contacts

• Study coordinator: Rikin Patel, DO
• Phone: +1 (908) 864 2991

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.