None listed
Conditions
Interventions
Intervention1: SINGLE INTRA-ARTICULAR INJECTION: 50 MILLION ALLOGENIC BONE MARROW DERIVED MESENCHYMAL STEM CELLS
Control Intervention1: STANDARD TREATMENT: NIL
Sponsors
ADVANCED NEUROSCIENCE ALLIES PRIVATE LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: 1) History of primary idiopathic osteoarthritis of the knee characterized by pain of moderate intensity. 2) Self-reported difficulty in at least one of the following activities attributed to knee pain: lifting and carrying groceries, walking 400 meters, getting in and out of a chair, or going up and down stairs. 3) Radiographic evidence of grade 1 to 3 osteoarthritis based on the Kellgren and Lawrence radiographic entry criteria. 4) Daily pain on activity and persistent pain despite the use of other anti-inflammatory or analgesic treatments. 5) Patients who have been on stable medication for the past three months. 6) Able to complete a 2-week washout period during which NSAIDs are prohibited. 7) Patients who have not received intra-articular steroids or hyaluronan within the last 3 months. 8) 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, including arthroscopy, or major trauma to the study joint in the previous 12 months 3) 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 after the washout period 4) Infections in or around the knee. 5) Patients awaiting a replacement knee or hip joint 6) Patients with other conditions that cause pain 7) Patients taking corticosteroid medication or Hyaluronan injection within last 3 months. 8) Significantly incapacitated or disabled and would be categorized as ACR Functional Class IV (largely or wholly incapacitated), or unable to walk without assistive devices 9) Patients with other known rheumatic or inflammatory disease such as rheumatoid arthritis 10) Positive hepatitis B surface antigen, hepatitis C antibody test, Anti human immunodeficiency virus (HIV) antibody test, or VDRL 11) Bleeding disorders 12) Known hypersensitivity to Hyaluronan products or animal sera 13) For women of child-bearing potential: positive pregnancy test or lack of contraceptive use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Safety and tolerance, assessed by adverse events 2) Patient's Assessment of Arthritis Pain [Osteoarthritis-Pain Visual analog scale (VAS)] 3) Aggregated Locomotor Function (ALF) scale 4) 6 minute walking testTimepoint: 3,6, 9 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Change from baseline in the WOMAC OA (Western Ontario and McMaster Universities Osteoarthritis) Index -pain subscale score 2 Reduction in intake of analgesic tablets 3 WOMAC Osteoarthritis stiffness Index 4 WOMAC Osteoarthritis Composite Index 5 Joint space width after 6 and 12 months 6 Cartilage volume in the different regions of the knee after 6 and 12 months 7 Joint radiographs- Joint space width Timepoint: 1,3,6,9 AND 12 MONTHS | — |
Countries
India
Contacts
Public ContactVIJAYALAKSHMI A.
Outcome results
None listed