Status:
NOT_YET_RECRUITING
Safety and Tolerability of StroMel™ in Subjects with Moderate to Severe Osteoarthritis of the Knee Joint
Lead Sponsor:
Akan Biosciences, LLC
Conditions:
Osteo Arthritis Knee
Eligibility:
All Genders
25-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The aim of this trial is to evaluate the safety and tolerability of autologous StroMel™ for the treatment of moderate to severe OA of the knee joint.
Eligibility Criteria
Inclusion
- Adults between the ages of 25-65 years
- Body Mass Index (BMI) less than 40 kg/m2
- Ambulatory and in good general health as described by vital signs (blood pressure 90/60 mm Hg to 120/80 mm Hg, pulse rate 60-100 beats per minute, temperature 97.2-99.1 °F) and normal blood chemistry.
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain score of ≥ 11 (worst possible = 20) over the previous 7 days
- OA of the knee with Kellgren and Lawrence radiographic classification (Grade 2-4 inclusive) within the last 6 months
- Minimum score of 40 out of possible 100 on the VAS (Visual Analog Scale) for pain.
- Patients who have failed to adequately respond for at least 6 months to at least 2 OA therapies that include conservative, non-pharmacological therapy and simple analgesics (e.g., acetaminophen); nonsteroidal anti-inflammatory drugs (NSAIDS); avoidance of activities that cause joint pain; exercise; weight loss; physical therapy; and removal of excess fluid from the knee.
- Have suitable knee joint anatomy for intra-articular injection.
- For adults of reproductive potential: use of effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.
Exclusion
- Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease.
- Subject with an infection that requires parenteral antibiotic administration.
- Active infection or crystal disease in the index joint within 1 month of screening
- History of fracture in the index limb, joint instability, or history of acute dislocation within 12 months of screening, or fracture with sequelae at any time
- Intra-articular treatment of any joint with any of the following agents within 6 months of screening: Any corticosteroid preparation (investigational or marketed), sodium hyaluronate, any biologic agent (e.g., platelet rich plasma (PRP) injection, stem cells, prolotherapy, amniotic fluid injection); investigational six months prior to enrollment.
- Presence of surgical hardware or other foreign body in the index joint
- Subjects who were administered with immunosuppressants such as cyclosporin A or azathioprine within 6 weeks before screening.
- Planned or anticipated surgery of the joint during the study period
- Allergies to anesthesia
- Subjects who tested positive for HIV, HCV, WNV, CMV, HBV, HTLV, ZIKA, syphilis, flu or COVID-19. Note: CMV is not a relevant communicable disease agent. A subject who tests positive or reactive for CMV is not necessarily ineligible. Physicians will determine donor eligibility for subjects with positive CMV test results.
- History of lipid disorders: lipedema, lipomatosis, or lipodystrophies.
- Active cancer, chemotherapy, or other malignancies in the last 6 months.
- Recent history of DVT or pulmonary embolism requiring anticoagulants or other medicines per the hematologist.
- Subject who participated in another clinical trial within 3 months before the screening visit
- Any illness which, in the Investigator's judgment, will interfere with the subject's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results.
- Subjects who are breastfeeding
- Subjects with uncontrolled arrhythmias
- Subjects with hemophilia; factor II, V, VII, X, or XII deficiencies; or Von Willebrand's disease.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04750252
Start Date
October 1 2025
End Date
August 31 2027
Last Update
January 29 2025
Active Locations (1)
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1
Mukesh
Gaithersburg, Maryland, United States, 20879