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 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? Entailment