Who is eligible for clinical trial NCT04750252?

Participants must meet the protocol's inclusion criteria for Osteo Arthritis Knee. The stated age range is 25 Years to 65 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT04750252 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-01-27

Safety and Tolerability of StroMel™ in Subjects with Moderate to Severe Osteoarthritis of the Knee Joint (NCT04750252)

An Open Label Study to Evaluate Safety and Tolerability of StroMel™ in Subjects with Moderate to Severe Osteoarthritis of the Knee Joint

🟡 Not Yet Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: Akan Biosciences, LLC

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (19 items).

Location: Mukesh — Gaithersburg, Maryland

Age range: 25 Years to 65 Years

🧪 Interventions in This Study

StroMel (BIOLOGICAL)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Mukesh — Gaithersburg, Maryland

📞 Contact the Study Coordinator

Phone: (240) 750-4893

Email: mkumar@fdamap.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Osteo Arthritis Knee

Bone Marrow Aspirate Concentrate (BMAC)Treatment for Knee Osteoarthritis — La Jolla, California
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization — Birmingham, Alabama
The Role of Vitamin K on Knee Osteoarthritis Outcomes — Boston, Massachusetts
Radiographic Migration Analysis of the ATTUNE Cementless CR Fixed-Bearing Total Knee Replacement — Winnipeg, Manitoba
Effects of Vitamin K on Lower-extremity Function in Adults With Osteoarthritis: — Boston, Massachusetts

Explore by condition: All Osteo Arthritis Knee clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗