Cell Therapy With Cellistem-OA for Symptomatic Knee Osteoarthritis

NCT04863183 | Unknown Phase 1 DMC

• 1 other identifier: OA-01
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Symptomatic knee osteoarthritis is a serious public health problem in the world, it carries a high personal, social and economic impact. Currently, there are no drugs that modify the natural course of the disease. As analgesic therapy becomes insufficient, more invasive measures are applied, ultimately leading to arthroplasty. The scientific community has joined efforts to develop new therapeutic approaches that allow the delay and regeneration of injured tissue in these patients. These include cell therapy with mesenchymal stem cells derived from different sources. Although most of the clinical studies carried out in different parts of the world with this therapy in patients with knee osteoarthritis have shown therapeutic benefit, it is necessary to develop clinical trials with high quality in our population. The aim of this project is to evaluate the safety, tolerance and efficacy of Cellistem-OA (biological therapy based on mesenchymal stem cells derived from Wharton's jelly of umbilical cord) in patients with knee osteoarthritis in the Colombian population. Investigators proposed to carry out an experimental (clinical trial), randomized, controlled and parallel with 30 participants with knee knee osteoarthritis of the medical complex Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle. The participants will be randomized into two groups: i) 15 patients who will receive a dose of 2 x 106 Cellistem-OA and ii) 15 patients who will receive an active comparator (acetonide of triamcinolone 10mg / mL), which will be administered by intra-articular injection in the superolateral aspect of the knee. The outcomes to be evaluated will be: (i) decrease in joint pain, (ii) increase in joint functionality, (iii) improvement in quality of life and (iv) improvement of articular cartilage. These parameters will be evaluated at weeks 1, 4, 8, 12, 24, 25, 28, 32, 36 and 52 post-treatments. Additionally, local and systemic adverse events will be recorded to establish whether or not there is an association between them and the intervention.

Conditions

Mesenchymal Stem Cells; Knee Osteoarthritis; Cell Therapy

Outcome Measures

Primary Outcomes (4)

• Decrease in joint pain

  Pain will be measured through visual analog scale (VAS).

  12 months

• Increased joint functionality

  Joint functionality will be measured through the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

  12 months

• Improvement in the quality of life

  Quality of life will be measured through the Short Form 36 Health Survey Questionnaire (SF-36).

  12 months

• Imaging improvement of articular cartilage

  The improvement of articular cartilage will be evaluated by nuclear magnetic resonance (NMR).

  12 months

Study Arms (2)

Group 1 (control-Triamcinolone acetonide)

ACTIVE COMPARATOR

Triamcinolone acetonide (10mg / mL) via intra-articular, 5 cc, one dose (zero time).

Drug: Triamcinolone acetonide

Group 2 (experimental- CELLISTEM-OA)

EXPERIMENTAL

CELLISTEM-OA via intra-articular, doses of 2 x 106 mesenchymal stem cells in 5cc of saline solution, one dose (zero time).

Biological: CELLISTEM-OA

Interventions

CELLISTEM-OA BIOLOGICAL

The intra-articular puncture will be performed by an orthopedic doctor specializing in knee and hip treatments. The procedure will be carried out using sterile technique, after cooling the skin with local ice.

Also known as: Mesenchymal stem cells

Group 2 (experimental- CELLISTEM-OA)

Triamcinolone acetonide DRUG

The intra-articular puncture will be performed by an orthopedic doctor specializing in knee and hip treatments. The procedure will be carried out using sterile technique, after cooling the skin with local ice.

Also known as: Kenacort-A

Group 1 (control-Triamcinolone acetonide)

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who / with:
• Osteoarthritis of the knee.
• Kellgren II or III to knee radiography.
• to 75 years inclusive.
• Pain scale greater than 40 over 100 mm.
• MRI with G I, II or III chondral knee injury with or without stable degenerative meniscal injury.
• Stable knee.
• Examination of the rest of the normal limb.
• Willingness to participate in the study for 1 year.
• Ability to understand and willingness to sign the informed consent.

You may not qualify if:

• Patients who / with:
• Symptomatic contralateral knee osteoarthritis.
• Significant knee trauma in the preceding 3 months.
• Wound or skin lesion in the knee studied.
• Anatomical valgus greater than 10º.
• Anatomical varus greater than 5º.
• Clinically significant joint effusion.
• Edema greater than 20% of the surface of the plateau or condyle in NMR.
• Previously known alterations in the hip and / or spine.
• Predominant patellofemoral pathology (radiographs with IWANO II osteoarthritis or more).
• Any type of inflammatory arthritis.
• History of active infections including HIV, HBV and HCV.
• Results of laboratory tests (hemogram and CRP) outside the normal ranges.
• Presence of fever on day -1 or day 0.
• Use of oral corticosteroids.

Sponsors & Collaborators

• Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle: lead
• Cells for Cells: collaborator

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Triamcinolone Acetonide; Triamcinolone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Martha L Arango, PhD

  Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martha L Arango, PhD

CONTACT

(57) 3226816547; martha.arango@foscal.com.co

Omar Amado, MD

CONTACT

(57)3108595352; omaramado85@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The Center for Advanced Therapies will send a pre-filled syringe with the 5 cc of solution without any difference in its external appearance, regardless of the content, according to the previously randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Technical and Scientific Centro de Terapias Avanzadas Fundación Ofalmológica de Santander

Model Details: Controlled, randomized, double-blind clinical trial comparing CELLISTEM-OA and active comparator (triamcinolone acetonide).

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 28, 2021
• Study Start: June 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share