Therapeutic and immunogenic effects of implanting Wharton’s jelly-derived mesenchymal stem cells into the knee joint of osteoarthritis patients in grade 2 & 3 Kellgren Lawrence scale: an interventional randomized double-blind placebo controlled clinical trial, phase I

Examination of therapeutic and immunogenic effects of implanting Wharton’s jelly (umbilical cord)-derived mesenchymal stem cells into knee joint of osteoarthritis patients in grade 2&3 Kellgren Lawrence scale

Interventional randomized double-blind placebo controlled clinical trial with a parallel group design of 40 patients in phase I. SAS 9.1 software will be used for randomization.

This study evaluates the efficiency of allogenic mesenchymal stem cells (produced under GMP standard) in osteoarthritis treatment being tested on patients referring to Chamran Hospital.

Inclusion criteria include Knee osteoarthritis (grade 2 & 3 Kellgren Lawrence scale), knee and femur malalignment of less than 30 degree, VAS pain level of 4-7 measured 24 hours prior to referral, Age between 40-65 years, Female/Male and Given informed consent. Exclusion criteria include Inflammatory and Autoimmune disorders, Cancer or severe diseases, Metabolic disorders, Immunodeficiency, Contagious viral infections, Psychological disorders, Liver or kidney failure, BMI of more than 30 Kg/m2, Fever, Oral corticosteroids intake during the last 4 weeks, Corticosteroids infusion during the last 6 months, Hypersensitivity to proteins or other components of culture medium, Blood clotting disorders, Pregnant women or women planning for a pregnancy during the last 1 year, Participating in another clinical trial at the same time, Septic arthritis and Addiction to drug/ alcohol/ painkillers/ or anesthetic substance.

The intervention group will receive hyaluronic acid (XHA) scaffold loaded with Wharton's jelly-derived mesenchymal stem cells and the control group will only receive HXA scaffold.

Improvement of walking pattern, physical activity and ability to perform daily routines, and reduction of inflammation and pain.

Using SAS 9.1 software, a random number table will be designed. The participants will randomly receive the random numbers placed in similar, sealed, and non-transparent envelopes. They will choose an envelope once visiting the doctor. Accordingly, the participants will be divided into control and intervention groups. The envelopes will be kept with a researcher who is neither participating in the study nor is aware of the study design until data collection phase. Only in case of emergency and sever complications, the principal project executor asks the researcher to open the related envelope.

All the data and observations will be published after analysis.

After follow up and data gathering, evaluation of immunogenicity and efficiency of cell injection, and writing the paper which is approximately 3 months after follow up, the data file will be released.

Activity in cell therapy domain is the only parameter to provide eligibility for access to our data and documents. The access is not limited to researchers and experts working in places other than universities or research centers can also have access to our documents.

Since the immunogenicity is evaluated in phase 1, there is no need to perform analysis other than items mentioned in proposal. Both Chamran Hospital and Celltech Company must be referenced in case of any use of our documents and data.

Contact documentation section of CellTech Pharmed company via m.ziraksaz@outlook.com or Dr. Mahdavi Health Research Centre via mahdavi.ag@gmail.com

The applicants must provide us with documents indicative of their activity in cell therapy domain and prove their need to have access to the documents related to this study.