Actively Recruiting
A Study of Human Allogeneic Bone-marrow Derived Mesenchymal Stromal Cell Product (StromaForte) in Patients With Musculoskeletal Injuries and/or Degeneration
Led by Cellcolabs Clinical LTD. · Updated on 2024-04-19
30
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Human Allogeneic Bone-marrow Derived Mesenchymal Stromal Cell Product (StromaForte) in Patients With Musculoskeletal Injuries and/or Degeneration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent and comply with all study procedures
- Aged 18 years or older at the time of consent
- Diagnosed with any musculoskeletal injury and/or degenerative condition
You will not qualify if you...
- Unable or unwilling to complete required study assessments
- Injury expected to heal completely within 14 days without lasting effects
- Injury unlikely to respond to the study treatment based on scientific evidence
- Traumatic head, skull, teeth, or jaw injury as main diagnosis
- Injury requiring untreated orthopedic surgery
- End stage liver or kidney disease
- History of cancer within last 2.5 years except certain treated skin or cervical cancers
- Life expectancy less than 1 year as judged by the investigator
- Positive for Hepatitis B, active Hepatitis C, HIV, or syphilis
- Recent severe heart conditions including unstable angina, severe peripheral artery disease, congestive heart failure (NYHA Class IV), or low ejection fraction (<25%)
- Uncontrolled high blood pressure (systolic >220 mm Hg or diastolic >150 mm Hg)
- Recent coronary artery procedures or heart attack within past month
- Severe chronic lung disease exacerbation
- Cognitive or language barriers preventing informed consent
- Severe acute infection at screening
- Pregnant or breastfeeding
- Participation in another investigational study within 30 days
- Any condition or treatment that might interfere with study results or full participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Live Well
Nassau, The Bahamas, The Bahamas
Actively Recruiting
Research Team
R
Rikin Patel, DO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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