Mesenchymal Stem Cell Treatment for Primary Osteoarthritis Knee

NCT02544802 | Completed Phase 1 DMC

• 1 other identifier: SB-VGH-201102
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and preliminary efficacy of autologous adipose-derived mesenchymal stem cells (ADMSCs) treatment for patients with primary osteoarthritis knee. Three intra-articular injections of autologous ADMSCs will be performed to subjects at a weekly interval.

Conditions

Osteoarthritis Knee

Outcome Measures

Primary Outcomes (1)

• Safety of intra-articular injection of autologous ADMSCs by incidence of adverse events and alterations in vital signs, blood chemistry profiles, complete blood count, urinalysis, and also the physical examination of the knees.

  12 months

Secondary Outcomes (6)

• Clinical assessment of visual analogue scale (VAS)

  12 months

• Clinical assessment of Short Form 36 questionnaire (SF-36)

  12 months

• Clinical assessment of Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  12 months

• Clinical assessment of Hospital for Special Surgery (HSS) Knee Score

  12 months

• Clinical imaging assessment of knee X-ray

  12 months

Study Arms (1)

ADMSCs

EXPERIMENTAL

Three intra-articular injections of ADMSCs at the dose of 8\~10x10\^6 cells/injection

Drug: Adipose-Derived Mesenchymal Stem Cells

Interventions

Adipose-Derived Mesenchymal Stem Cells DRUG

ADMSCs

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has bilateral Kellgren and Lawrence grade II-III primary osteoarthritis as determined by X-ray.
• Subject's pain score is 8-13 points (Lequesne's index).
• Ages between 50-70 years.
• Signed informed consent from the subject.
• Female subjects should be post-menopausal women

You may not qualify if:

• Subject infected with hepatitis B, hepatitis C, HIV, syphilis or HTLV.
• Subject not suitable for liposuction surgery.
• Subject with hypersensitivity/allergy to anesthetic.
• Subject's creatinine values higher than 1.6mg/dl.
• Subject with body mass index, BMI over 30.
• Subject's studied knee treated with intra-articular injection therapy within 6 months prior to screen.
• Subject has undergone surgery on either side of knee, including fracture surgery, arthroscopic surgery, meniscus repair surgery, or cruciate ligament reconstruction surgery.
• Subject enrolled in any other cell therapy studies within the past 30 days.
• Subject who the investigator considers inappropriate for the clinical trial due to any other reasons than those listed above.
• Subject has a history of gouty arthritis, septic arthritis, rheumatoid arthritis and any other autoimmune arthritis of the knee joint.
• Subject has had major medical problems in vital organs, such as; heart, liver, kidney, or lung.

Sponsors & Collaborators

• Steminent Biotherapeutics Inc.: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2015
• First Posted: September 9, 2015
• Study Start: June 1, 2015
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: October 28, 2022

Record last verified: 2022-10

Locations

TW (1)