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

NCT03308006 | Completed Phase 2

• 1 other identifier: IRB 2018-04
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Regenerated cartilage

  Histological assessment of regenerated cartilage

  One year

Study Arms (1)

Stem cells therapy

EXPERIMENTAL

Biological: Stem cells

Interventions

Stem cells BIOLOGICAL

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.

Stem cells therapy

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Study Sites (1)

King Faisal Sepcialist Hospital and Research Center

Jeddah, Saudi Arabia

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• . Zainullah Al Shareef, MD

  King Faisal Specialist Hospital & Research Cener -Jeddah

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2017
• First Posted: October 12, 2017
• Study Start: January 1, 2018
• Primary Completion: December 30, 2018
• Study Completion: April 12, 2023
• Last Updated: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)