Clinical trial: Impact of Mesenchymal Stem Cells in Knee Osteoarthritis (NCT03477942)

Eligibility criteria:
Inclusion Criteria:

        Knee Osteoarthritis Subjects

          1. Male or female 18-60 years of age

          2. Confirmed diagnosis of knee osteoarthritis based on clinical and radiographic findings

          3. Unilateral chronic knee pain >4 months

          4. Imaging findings consistent with mild-moderate generalized cartilage degeneration (MRI
             chondropathy or radiographic changes)

          5. Failed non-invasive modalities of treatment

          6. Subjects must have the ability to understand and the willingness to sign a written
             informed consent document

          7. For women of childbearing potential: agreement to remain abstinent (refrain from
             heterosexual intercourse) or use a contraceptive method with a failure rate of <1% per
             year during the treatment period. A woman is considered to be of childbearing
             potential if she is postmenarcheal, has not reached a postmenopausal state (<12
             continuous months of amenorrhea with no identified cause other than menopause), and
             has not undergone surgical sterilization (removal of ovaries and/or uterus). Examples
             of contraceptive methods with a failure rate of <1% per year include bilateral tubal
             ligation, male sterilization, hormonal contraceptive that inhibit ovulation,
             hormone-releasing intrauterine devices, and copper intrauterine devices. The
             reliability of sexual abstinence should be evaluated in relation to the duration of
             the clinical trial and the preferred and usual lifestyle of the patient. Period
             abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and
             withdrawal are not acceptable methods of contraception

        Focal Chondral Defect Subjects

        Inclusion Criteria:

          1. Male or female 18-60 year of age

          2. Knee pain and/or effusion

          3. Inability to continue or difficulty in participation in recreational or professional
             sport

          4. MRI with Outerbridge Grade 4 focal chondral defect

          5. Subjects must have the ability to understand and the willingness to sign a written
             informed consent document

          6. For women of childbearing potential: agreement to remain abstinent (refrain from
             heterosexual intercourse) or use a contraceptive method with a failure rate of <1% per
             year during the treatment period. A woman is considered to be of childbearing
             potential if she is postmenarcheal, has not reached a postmenopausal state (<12
             continuous months of amenorrhea with no identified cause other than menopause), and
             has not undergone surgical sterilization (removal of ovaries and/or uterus). Examples
             of contraceptive methods with a failure rate of <1% per year include bilateral tubal
             ligation, male sterilization, hormonal contraceptive that inhibit ovulation,
             hormone-releasing intrauterine devices, and copper intrauterine devices. The
             reliability of sexual abstinence should be evaluated in relation to the duration of
             the clinical trial and the preferred and usual lifestyle of the patient. Period
             abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and
             withdrawal are not acceptable methods of contraception.

        Exclusion Criteria:

          1. Radiographic findings consistent with Kellgren-Lawrence Stage 4 disease

          2. Focal chondral defect

          3. Major axial deviation (>5 degrees varus or valgus)

          4. Concomitant ligamentous or meniscal injury

          5. BMI > 40 as defined by NIH Clinical Guidelines Body Mass Index

          6. Women who are pregnant, breastfeeding or unwilling to practice birth control during
             participation in the study

          7. Concurrent participation in another investigational trial involving systemic
             administration of agents (within the previous 30 days), or have received prior
             intra-articular injection of any form

             • Or plans to participate in any other allogeneic stem cell therapy trial during the
             2-year follow-up period

          8. Symptomatic active cardiac or respiratory disease that requires scheduled use of
             medication

          9. Neurologic disorder including, but not limited to epilepsy, Parkinson's disease,
             dementia, cerebrovascular disease, tumor of the nervous system, and amyotrophic
             lateral sclerosis.

         10. Psychiatric disorder including, but not limited to schizophrenia, bipolar disorder,
             personality disorder, depression, anxiety, or any other mental illness that would
             prevent the completion of the study

         11. Current immunosuppression from medication or disease

         12. History of systemic malignancy

         13. History of infection with hepatitis B, C, or HIV

         14. History of inflammatory arthropathy

         15. History of prior local knee infection

         16. Major surgeries, other than diagnostic surgery within 4 weeks

         17. Contraindication to MRI:

               -  Indwelling medical devices such as pacemakers, aneurysm clips, etc.

               -  Indwelling metal from any other cause (trauma, etc.). To be excluded with history
                  and/or radiographs, as necessary

         18. Screening hematology with white blood cell count < 4.5 x 109 cells/L, hematocrit <30%,
             and platelets <150 x 109 platelets/L

         19. Have a known history of hypersensitivity or anaphylactic reaction to Dimethyl
             sulfoxide (DMSO)

         20. Have been treated in the last 6 months before enrollment for alcohol and/or drug abuse
             in an inpatient substance abuse program

         21. Subject unlikely to complete the study as determined by the Investigator

         22. Subjects must have normal marrow function, and be clinically stable with no
             significant changes in health status within 2 weeks prior to cell collection that the
             PI/Sub-Investigator deems relevant to exclude from participation. (See below for
             details of the cell collection procedure)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 60 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