Using stem cells to treat musculoskeletal injuries and degeneration

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

This study is testing whether a new stem cell treatment can help people with musculoskeletal injuries and degeneration feel better and recover.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cellcolabs Clinical LTD. (Industry-sponsored)
• Locations: 1 site (Nassau, The Bahamas)
• Trial ID: NCT06074783 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with diagnosed musculoskeletal injuries or degenerative conditions.

Not a fit: Patients with injuries expected to heal on their own within 14 days or those requiring orthopedic surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve pain management and functional recovery for patients with musculoskeletal injuries.

How similar studies have performed: While the use of stem cells in treating musculoskeletal conditions is a growing field, this specific approach with StromaForte is novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Nassau, The Bahamas

• Live Well — Nassau, The Bahamas, The Bahamas (Recruiting)

Study contacts

• Study coordinator: Rikin Patel, DO

Conditions Musculoskeletal Injury