Health Condition 1: null- Articular Cartilage Defects of the Articulating Joint(s).
Conditions
Interventions
Intervention1: CHONDRON (Autologous Adult Live Cultured Chondrocytes): Colourless transparent vial product, which contains mixed precipitated pale-white-coloured autologous adult live cultured chondro
Sponsors
Regenerative Medical Services Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female subjects aged 18 to 65 years (both inclusive) with focal, ICRS (grade III or IV) articular cartilage defects on the weight bearing surface of the articulating joint(s). 2.Subjects with articular cartilage defects of the articulating joint diagnosed by visual examination, digital X-Ray and MRI (size of the defect more than 1 cm2 or less than 15 cm2). 3.Subjects with intact meniscus, stable knee, with normal alignment (corrective procedure may be performed in combination with or prior to biopsy) with a normal joint space with no inflammation or arthritic changes in the joint. 4.Subjects reported with bilateral defects shall be included, however only unilateral defect will be treated at a time and not together. 5.Subject is willing and able to comply with post-operative weight-bearing restrictions and rehabilitation. 6.Body mass index (BMI) 7.Subjects (or legally acceptable representative [LAR] of impartial witness) who are able to provide written informed consent prior to participation in the study.
Exclusion criteria
Exclusion criteria: 1.Subjects with degenerative changes like osteoarthritis and recommended for total knee replacement avascular necrosis and articular cartilage defects with kissing lesions. 2.Subjects with tibio-femoral mal-alignment of articulating joints, instability of articulating joint ligament, and/or bone defects around area of defective cartilage. 3.Subjects with inflammatory arthritis, such as osteoarthritis and gouty arthritis. 4.Subjects with autoimmune disease related rheumatoid arthritis. 5.Subjects who are pregnant, breast-feeding or have childbearing potential and have had a positive pregnancy test prior to receiving the therapy. 6.Subjects with malignant tumors, who have undergone radiotherapy or chemotherapy within last 2 years. 7.Subjects with type 1 or type 2 Diabetes Mellitus having pre-prandial blood glucose levels >130mg/dL and post prandial blood glucose levels >180 mg/dL at screening visit. 8.Subjects with acute infections, currently on treatment with antibiotics and antimicrobials will not be included. Such subjects may be considered after completion of adequate treatment and as per Investigatorâ??s discretion. 9.Subjects under adrenocorticoid therapy and/or history of alcohol or drug abuse/dependency. 10.Subjects with psychiatric disorders who are considered inappropriate to participate in this study by the Principal Investigator. Subjects with Psychiatric disorders who are on stable medication may be included in the study as per Investigatorâ??s discretion. 11.History of receiving an investigational product within 30 days prior to enrollment in this study. 12.Subjects who are tested positive for HIV, Hepatitis B or Hepatitis C and Syphilis. 13.Subjects who are diagnosed with tuberculosis at the time of Screening. 14.Subjects who have hemoglobinopathies such as and not limited to sickle cell anemia, leukaemia and thalassemia. 15.Subjects who have ongoing history of cardiac, renal and hepatic dysfunctions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety of the Autologous Adult Live Cultured Chondrocytes (CHONDRON®) implantation in articular cartilage defects of the articulating joint(s).Timepoint: 03 months after implantation | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Autologous Adult Live Cultured Chondrocytes (CHONDRON®) implantation in articular cartilage defects of the articulating joint(s).Timepoint: 06 months after implantation | — |
Countries
India
Contacts
Public ContactDr Ashoka Kumar Singh
Veeda Clinical Research Pvt. Ltd.
Outcome results
None listed