Safety of Allogeneic Bone Marrow Derived Mesenchymal Stem Cells in Subjects With Osteoarthritis

Phase I, Open Label Study to Assess the Safety and Tolerance of a Single Intraarticular Dose of STEMEDICA's Human Allogeneic Bone Marrow Derived Mesenchymal Stem Cells, in Subjects With Knee Osteoarthritis.

The aim of this study is to assess the safety of Stemedica's mesenchymal stem cells in patients with knee osteoarthritis. The route of administration is intraarticular. Safety will be evaluated by AE/SAE incidence and administration tolerance. The subjects will undergo follow-up for 52 weeks. The target population is subjects with knee osteoarthritis (grade II-III in Kellgren-Lawrence scale).

Inclusion Criteria:

• Male or female volunteers between 35-65 years.
• X-ray evidence of osteoarthritis (grade II-III in Kellgren-Lawrence).
• Chronic joint pain (>5 visual analogue scale) in knee.
• BMI ≤ 29.
• Voluntary acceptance and signature of informed consent.
• Willing to attend study visits and lab sample recollection.
• Lab values within normal reference values.
• Willing to use effective birth control methods.

Exclusion Criteria:

• Inflammatory arthritis.
• Generalized infection.
• Active cancer or history of cancer in the past 5 years.
• Receiving oral or intraarticular steroids.
• Positive labs for HIV, Hepatitis B or C.
• Recent trauma in the target joint.
• Debris in joint.
• Subjects that have undergone or need to undergo arthroscopic knee surgery in the target joint.
• History of joint substitution, intraarticular fractures, osteotomy, arthroplasty or menisectomy.
• Clinically significant knee misalignment.
• Other illnesses that the investigator considers clinically significant.
• Participating in another clinical trial three months before enrolling.
• Women that are pregnant, lactating or result positive in the pregnancy test during screening.
• Known allergies to bovine products.
• Subjects taking anticoagulants.