Health Condition 1: null- Osteoarthritis of knee joint
Conditions
Interventions
Intervention1: Allogeneic mesenchymal stem cells: Bone marrow derived mesenchymal stem cells, 2 - 4 ml, single dose, intraarticular
Control Intervention1: Placebo: Plasmalyte-A, 2 - 4 ml, single dose,
Sponsors
Stempeutics Research Pvt Ltd
Manipal Acunova Limited
Eligibility
Inclusion 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 entry 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
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 VDRL 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability, assessed by adverse eventsTimepoint: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change from baseline in the WOMAC OA Index -pain subscale score 2. WOMAC Osteoarthritis stiffness Index 3. WOMAC Osteoarthritis Composite Index 4. ICOAP (Intermittent and Constant Osteoarthritis Pain) 5. Radiograph of knee 6. WORMS scoring system using MRI of the knee after 6 and 12 months 7. Patients Assessment of Arthritis Pain [Osteoarthritis-Pain Visual analog scale (VAS)] 8. Reduction in intake of analgesic tabletsTimepoint: 2 year | — |
Countries
India
Contacts
Public ContactJijy Abraham
Stempeutics Research Pvt. Ltd.
Outcome results
None listed