Clinical trial: Allogeneic Mesenchymal Stem Cells in Osteoarthritis (NCT01453738)

Eligibility criteria:
Inclusion Criteria:

          1. Males or females in the age 40 - 70 years (both inclusive)

          2. Radiographic evidence of grade 2 to 3 osteoarthritis based on the Kellgren and
             Lawrence radiographic criteria.

          3. History of primary idiopathic osteoarthritis of the knee characterized by pain which
             requires intake of analgesics.

          4. Self-reported difficulty in at least one of the following activities attributed to
             knee pain: lifting and carrying groceries, walking 400 metres, getting in and out of a
             chair, or going up and down stairs.

          5. Patients who have been on stable medication which may be NSAIDs / Opioid or opiate
             analgesics, for the past three months.

          6. Female patients of childbearing age must be willing to use accepted methods of
             contraception during the course of the study

          7. Ability to provide written informed consent.

        Exclusion Criteria:

          1. Prior or ongoing medical conditions (e.g., concomitant illness, psychiatric condition,
             alcoholism, drug abuse), medical history, physical findings, ECG findings, or
             laboratory abnormality that, in the investigator's opinion, could adversely affect the
             safety of the subject, makes it unlikely that the course of treatment or follow-up
             would be completed, or could impair the assessment of study results.

          2. History of surgery, or major trauma to the study joint

          3. Arthroscopy on the study joint in the previous 12 months

          4. Signs of active study joint inflammation including redness, warmth, and/or, if
             qualifying with osteoarthritis of the knee, a large, bulging effusion of the study
             knee joint with the loss of normal contour of the joint at the screening visit or at
             the baseline examination

          5. Patients who had received intraarticular steroids or hyaluronan within the last three
             months.

          6. Infections in or around the knee.

          7. Patients awaiting a replacement knee or hip joint

          8. Patients with other conditions that cause pain

          9. Patients with deformity of the knee joint.

         10. Significantly incapacitated or disabled and would be categorized as ACR Functional
             Class IV (largely or wholly incapacitated), or unable to walk without assistive
             devices

         11. Patients with other known rheumatic or inflammatory disease such as rheumatoid
             arthritis

         12. Other pathologic lesions on x-rays of knee

         13. Positive hepatitis B surface antigen, hepatitis C antibody test, Anti human
             immunodeficiency virus (HIV) antibody test, or RPR

         14. History of Bleeding disorders

         15. Known hypersensitivity to Hyaluronan products or animal sera

         16. For women of child-bearing potential: positive pregnancy test or lactating [Females
             who are planning pregnancy within next one year should be excluded]
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 70 Years

Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Entailment