Actively Recruiting
A Patient Sponsored Ongoing Open-label Single-arm, Safety and Efficacy Study of Cellcolabs 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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Musculoskeletal disorders and injuries cause significant disability worldwide, affecting people of all ages and leading to pain, limited mobility, and reduced quality of life. This ongoing open-label, single-arm phase I/IIa study is evaluating the safety of a human allogeneic bone marrow-derived mesenchymal stromal cell product called StromaForte in patients with musculoskeletal injuries and/or degeneration. The study aims to assess safety and changes in pain over one year after treatment with these stem cells. Participants receive 50 million StromaForte cells locally injected under ultrasound guidance at the injury or degeneration site, combined with or without 100 million cells given intravenously over about 30 minutes. If local injection is not possible, only the systemic intravenous treatment is given. Additional doses may be administered with specified minimum intervals between local and systemic doses. Four subgroups based on connective tissue injury or degeneration type are included. During the study, patients are monitored for adverse events up to one year after treatment. Researchers assess pain levels in each injured or degenerated area, quality of life measures using questionnaires, and changes in pain between treatment subgroups. Follow-up can be face-to-face or remote. This comprehensive evaluation will provide data on safety and patient-reported outcomes following StromaForte administration for musculoskeletal conditions.
CONDITIONS
Brief 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
- Have any diagnosed musculoskeletal injury and/or degenerative condition
You will not qualify if you...
- Unable or unwilling to perform required assessments
- Have an injury expected to heal within 14 days without lasting effects
- Have an injury with solid evidence that the study treatment will have no effect
- Diagnosed with traumatic head, skull, teeth, or jaw injury as inclusion reason
- Require orthopedic surgery not yet addressed by local/home surgeon
- Have end-stage liver or renal disease
- History of malignancy within 2.5 years except certain treated skin or cervical cancers
- Conditions limiting lifespan to less than 1 year per investigator's discretion
- Positive for hepatitis B, active hepatitis C, HIV-1/2, or syphilis
- Have unstable angina, severe peripheral artery disease in last 2 months
- Have congestive heart failure NYHA Class IV or ejection fraction below 25%
- Uncontrolled hypertension above specified blood pressure thresholds
- Recent coronary artery bypass, angioplasty, revascularization, or myocardial infarction within past month
- Acute exacerbation of severe chronic obstructive lung disease
- Cognitive or language barriers preventing consent or study participation
- Severe acute infection at screening and treatment
- Pregnant or breastfeeding
- Participating or recently participated in another investigational therapeutic or device trial
- History or current evidence of conditions or therapies that could confound study results or interfere with full participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants receive local and/or intravenous infusions of human allogeneic bone marrow-derived mesenchymal stromal cells (MSCs) under ultrasound guidance for musculoskeletal injuries or degeneration. Additional doses may be given with minimum intervals of 2 months for local doses and 3 months for systemic doses.
Visits scheduled as needed for dosing and assessments during treatment
Duration - Up to 1 year
Participants are monitored for safety and efficacy outcomes including pain levels and quality of life up to one year after treatment initiation.
Periodic visits for assessments up to 1 year
Trial Site Locations
Total: 1 location
1
Live Well
Nassau, The Bahamas, The Bahamas
Actively Recruiting
Research Team
R
Rikin Patel, DO
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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