Knee Osteoarthritis Treatment With Adipose-derived Stem Cells: Phase II Clinical Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03308006|
Recruitment Status : Not yet recruiting
First Posted : October 12, 2017
Last Update Posted : August 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Biological: Stem cells||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Knee Osteoarthritis Treatment With Adipose-derived Stem Cells: Phase II Clinical Trial|
|Estimated Study Start Date :||December 20, 2018|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||June 30, 2019|
|Experimental: Stem cells therapy||
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 [ Time Frame: One year ]Histological assessment of regenerated cartilage
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03308006
|Contact: Bakr M Binsadiq, MD||00966503533309||BBinsadiq@kfshrc.edu.sa|
|Contact: Eman A Bawazeer, CRC||00966126677777 ext firstname.lastname@example.org|
|King Faisal Sepcialist Hospital and Research Center||Not yet recruiting|
|Jeddah, Saudi Arabia|
|Contact: Bakr Bin Sadiq, MD 00966126677777 ext 62984 email@example.com|
|Study Chair:||. Zainullah Al Shareef, MD||King Faisal Specialist Hospital & Research Cener -Jeddah|