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

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ClinicalTrials.gov Identifier: NCT03308006
Recruitment Status : Not yet recruiting
First Posted : October 12, 2017
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
King Faisal Specialist Hospital & Research Centre, Jeddah

Brief 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

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Biological: Stem cells Phase 2

Detailed 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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Regenerated cartilage [ Time Frame: One year ]
    Histological assessment of regenerated cartilage



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age between 45 and 65.
  • Participants having Knee osteoarthritis grade 2 or higher "Kellgren and Lawrence scale"
  • Participants had an average pain intensity of grade 4 or more on a 10-point visual analog for at least one year.

Exclusion Criteria:

  • Patient with history of rheumatic or chronic inflammatory diseases
  • Patient poorly controlled diabetes,
  • Patient who currently on OA treatment such as corticosteroids, chondroitin sulfate, glucosamine or hyaluronic acid.

Information from the National Library of Medicine

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


Contacts
Contact: Bakr M Binsadiq, MD 00966503533309 BBinsadiq@kfshrc.edu.sa
Contact: Eman A Bawazeer, CRC 00966126677777 ext 63544 ebawazeer@kfshrc.edu.sa

Locations
Saudi Arabia
King Faisal Sepcialist Hospital and Research Center Not yet recruiting
Jeddah, Saudi Arabia
Contact: Bakr Bin Sadiq, MD    00966126677777 ext 62984    bbinsadiq@kfshrc.edu.sa   
Sponsors and Collaborators
King Faisal Specialist Hospital & Research Centre, Jeddah
Investigators
Study Chair: . Zainullah Al Shareef, MD King Faisal Specialist Hospital & Research Cener -Jeddah

Responsible Party: King Faisal Specialist Hospital & Research Centre, Jeddah
ClinicalTrials.gov Identifier: NCT03308006     History of Changes
Other Study ID Numbers: IRB 2018-04
First Posted: October 12, 2017    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases