Impact of Mesenchymal Stem Cells in Knee Osteoarthritis

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
• •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.