Knee Osteoarthritis Treatment With Adipose-derived Stem Cells: Phase II Clinical Trial

STUDY DESIGN, LOCATION AND PATIENTS This study will be a single center phase II one arm clinical trial. It will be conducted at King Faisal Specialist Hospital &Research Center (Gen. Org.)-Jeddah. The decided sample size will be between 12 to 18 participants. Participants will be recruited from orthopedic clinics. Each patient will receive 1.0× 108 stem cells in 3 mL of normal saline.

All patients who are potentially eligible to be included in the study, and agreed to participate will be evaluated medically. Baseline assessment will involve complete general and orthopedic physical examination. Complete laboratory investigations and radiological investigations including diagnostic MRI of the knee to confirm the diagnosis will performed to each patient.

Inclusion Criteria In this study, participants will be considered as having Knee osteoarthritis if the patient's x-rays showed grade 2 or higher Kellgren and Lawrence scale. He/she will be potentially eligible to be included in the study if his/her age is between 45 and 65 years and diagnosed by orthopedic consultant as having idiopathic osteoarthritis of the knee and had an average pain intensity of grade 4 or more on a 10-point visual analog for at least one year.

Exclusion Criteria Patient will be excluded if she/he had history of chronic rheumatic or inflammatory diseases, poorly controlled diabetes, or currently on OA treatments.

Data collection Potentially eligible participants will receive verbal and formal written information about the study and invited to participate. Eligible participants who provide written consent to participate will be asked to fill out a well known reliable and valid Musculoskeletal Pain Questionnaire (The Orebro Musculoskeletal Pain Questionnaire).