A Phase 2 interventional study of Stem cells in Knee Osteoarthritis, sponsored by King Faisal Specialist Hospital & Research Centre, Jeddah. Completed at 1 site in Saudi Arabia. Open to participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-04-14.
Sponsored by King Faisal Specialist Hospital & Research Centre, Jeddah · Phase 2, Interventional, and Treatment
In 1990, the prevalence of osteoarthritis of the hip or knee was very low 3.5% in Saudi Arabia, it increased to 53.3% and 60.9% in male in female patients respectively in 2002. The existing management of OA is conservative and pharmacological management aiming to relief symptoms of osteoarthritis and improves joint function. Results of a Meta-Analysis showed that mesenchymal stem cell is effectiveness and safe to treat knee osteoarthritis. In 1990, the prevalence of osteoarthritis of the hip or knee was very low 3.5% in the Kingdom of Saudi Arabia and it increased to 53.3% and 60.9% in male in female patients respectively in 2002. Results of a Meta-Analysis showed that mesenchymal stem cell is effectiveness and safe to treat knee osteoarthritis. This study will be a single center phase II-one arm clinical trial. It will be conducted at KF SH\&RC-Jeddah. 18 participants will be recruited from orthopedic clinics. Participate will be evaluated before inclusion in the study. Participants will be exposed to e abdominal liposuction procedure under local anesthesia for stem cells harvesting. Stem cells will be separated from fat cells in the adipose tissue then activated in Tissue Culture Lab at Research Center- Jeddah. The activated stem cells will be injected into the knee joint via 22G spinal needle. The intra-articular stem cells injections will be performed under Ultrasound guidance at the theater under spinal anesthesia. Each patient will receive 1.0× 108 stem cells in 3 mL of normal saline
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).
Procedures The procedure of KOA stem cell therapy will be done in four stages, harvesting, separation, activation, and treatment stage. In summary, Participants in this phase II one arm clinical trial will be exposed to simple abdominal liposuction procedure under local anesthesia for stem cells harvesting. Stem cells will be separated from fat cells in the adipose tissue then activated in Tissue Culture Lab at Research Center- JEDDAH after that the activated stem cells will be injected into the knee joint via 22G spinal needle. The intra-articular stem cells injections will be performed under Ultrasound guidance at the theater under spinal anesthesia.
Personnel Simple abdominal Liposuction will be performed by accredited plastic surgeon. Qualified scientist and qualified and trained technicians will perform stem cells separation and activation under good manufacturing practice conditions, and orthopedic surgeon will perform intra-articular stem cells injections.
Outcome Measures Participants will be followed for one year after the date of stem cells knee joint injection and monitored and evaluated for serious adverse events, clinical outcomes, the size, depth and histological assessment of regenerated cartilage.
Statistical Analysis Categorical data will be summarized by measuring the frequency and percentage and measures of central tendency and dispersions will be used summarize numeric data. Paired t test and Wilcoxon signed rank test will be used to compare the changes from baseline in parametric and non-parametric data respectively. The analysis will be performed using SPSS version 16
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's enrollment of 18 is below the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →King Faisal Specialist Hospital & Research Centre, Jeddah is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: Stem cells
Participants will be exposed to e abdominal liposuction procedure under local anesthesia for stem cells harvesting. Stem cells will be separated from fat cells in the adipose tissue then activated in Tissue Culture Lab at Research Center- Jeddah. The activated stem cells will be injected into the knee joint via 22G spinal needle. The intra-articular stem cells injections will be performed under Ultrasound guidance at the theater under spinal anesthesia. Each patient will receive 1.0× 108 stem cells in 3 mL of normal saline.
Regenerated cartilage
Histological assessment of regenerated cartilage
Time frame: One year
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2018 to primary completion in Dec 2018, 11 months.
Of 43 non-industry phase 2 interventional studies under Osteoarthritis, Knee, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 61. This study's 11 months is below that.
Counting every sponsor, half of 101 studies reached it within 20 months; a quarter within 12 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Stem Cell
King Faisal Specialist Hospital & Research Centre, Jeddah