Health Condition 1: null- Osteoarthritis
Conditions
Interventions
Intervention1: Ex vivo cultured adult allogenic MSCs: Single dose of Allogenic MSCs (either 75million or 150 million cells ) suspended in plasmalyte A given as intra-articular injection
Control Inter
Sponsors
Stempeutics Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1) History of primary idiopathic osteoarthritis of the knee characterized by pain of moderate intensity which requires intake of analgesics at least 3 days a week. 2) 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. 3)Radiographic evidence of grade 1 to 3 osteoarthritis based on the Kellgren and Lawrence radiographic entry criteria.4) Patients who have been on stable medication for the past three months.5) Able to complete a 1-week washout period during which NSAIDs are prohibited. 6) Patients who have not received intraarticular steroids or hyaluronan within the last three months. 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, 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) Other pathologic lesions on x-rays of knee 11) Positive hepatitis B surface antigen, hepatitis C antibody test, Anti human immunodeficiency virus (HIV) antibody test, or VDRL. 12) Bleeding disorders. 13) Known hypersensitivity to Hyaluronan products or animal sera. 14) For women of child-bearing potential: positive pregnancy test or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Safety and tolerability, assessed by adverse events. The type of AE(s), number of AE(s) and proportion of patients with AE(s) . 2) Patients Assessment of Arthritis Pain [Osteoarthritis-Pain Visual analog scale (VAS)] 3)Aggregated Locomotor Function (ALF) scale. Timepoint: Baseline, 7th day, 1st month, 3rd month, 6th month, 9th month, 12th month. | — |
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) 6 minute walking test 4) WOMAC Osteoarthritis stiffness Index 5) WOMAC Osteoarthritis Composite Index 6) Joint space width 7) WORMS scoring system using MRI of the kneeTimepoint: Baseline, 1st month, 3rd month, 6th month, 9th month, 12th month 6 months and 12 months 6 months and 12 months | — |
Countries
India
Contacts
Public ContactJiji Abhraham
Stempeutics Research Pvt. Ltd.
Outcome results
None listed