Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03308006 |
Other study ID # |
IRB 2018-04 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 2
|
First received |
|
Last updated |
|
Start date |
January 1, 2018 |
Est. completion date |
April 12, 2023 |
Study information
Verified date |
April 2023 |
Source |
King Faisal Specialist Hospital & Research Centre, Jeddah |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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
Description:
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