A randomised, double-blind, comparator study to assess the safety & tolerability of a single injection into the knee joint of MSB-CAR001 when combined with Hyaluronan compared to Hyaluronan alone in patients who have recently undergone an Anterior Cruciate Ligament Reconstruction.

Exclusion Criteria29

• Women who are pregnant or breast feeding or planning to become pregnant during the study;
• Known sensitivities to bovine (cow), murine (mouse), chicken products and/or dimethylsulfoxide (DMSO);
• Known allergies to products from birds such as feathers, eggs or poultry;
• Previous allergic reaction to Hyaluronan;
• Systemic or local infection at the screen visit or at the time of the study injection;
• History of any autoimmune disease, such as, systemic lupus erythematosus, Addison’s disease, Crohn’s disease, or rheumatoid arthritis;
• Treatment with immunosuppression therapy within 6 months prior to screen (visit 1);
• Chronic (at least 7 consecutive days) of systemic corticosteroids at a dose equivalent to > 10 mg/day of prednisolone within 14 days prior to screen (Visit 1);
• Acute or chronic infectious disease, including but not limited to human immunodeficiency virus (HIV);
• Treatment and /or uncompleted follow-up treatment of any investigational therapy within 6 months before the procedure and /or intent to participate in any other investigational drug or cell therapy study during the 24 month follow-up period of this study;
• Recipient of prior allogeneic stem cell/progenitor cell therapy;
• Undergoing a simultaneous procedure to the opposite knee;
• Injury is work related and covered by workers compensation;
• A medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the study or potentially decrease survival or interfere with ambulation or rehabilitation (e.g., histories of transient ischemic attack (TIA), stroke, uncontrolled diabetes, or liver disease);
• Has antibody specificities to donor Human Leukocyte Antigens (HLA);
• History or current evidence of alcohol or drug abuse or is a recreational user of illicit drugs or prescription medications;
• Significant damage to the collateral or posterior ligaments of the knee;
• Meniscal injury requiring more than a 1/3 resection or more than a single suture to reconstruction or a reconstruction that will alter the usual ACL rehabilitation;
• History of prior surgery to the study knee joint;
• History of malignancy (excluding basal cell carcinoma that has been successfully excised);
• Chondral lesions noted at time of surgical reconstruction greater than Grade 1a on any surfaces;
• Intra-articular steroid or corticosteroid or Hyaluronan injections in preceding 3 months to the affected joint;
• Diffuse synovitis at time of surgery for the ACL reconstruction;
• Indwelling metal of any description which precludes MRI examination, such as but not limited to, indwelling pacemaker, cerebral aneurysm clips, or electrical indwelling device such as bone stimulator or anything that would preclude participant from undergoing screening MRI;
• Not willing to return for required follow-up visits or there is a clear demonstration of likely poor compliance;
• Any other medical condition that, in the judgment of the Principal Investigator/Investigators, would prohibit the patient from participating in the study.
• Patient is legally or mentally incapacitated;
• Prisoners or participants who are involuntarily incarcerated;
• Participants who are compulsorily detained for treatment of a psychiatric disorder.