WHARTON JELLY ORIGINATED MESENCHIAL STEM CELL in GONARTHROSIS

NCT04313894 | Unknown Phase 2

• 1 other identifier: 2015/397
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoarthritis (OA) is a progressive disease characterized by degeneration of the joint cartilage, which is involved in the immune system leading to proinflammatory cytokine and metalloproteinase release. Knee osteoarthritis is the most common form. The healing is very slow and the damage is not fully recovered, so the degeneration process continues and no treatment modalities completely remove this process. Various methods are used in the treatment of OA and total joint replacement is performed in the patients with OA recently. Ten patients with Kellgren-Lawrence grade II-III knee OA who had been applied for knee pain and received conservative treatment for 6 months and had no benefit will be taken to study. Patients will be assessed 7 (V1-7) times during the study. Clinical, immunologic and radiological treatment effectiveness and clinical improvement will be evaluated at the beginning of the treatment and in all follow-up patients participating in the study.

Conditions

Stem Cell; Gonarthrosis

Keywords

Gonarthrosis; Degenerative Arthritis Treatment; Stem Cell Therapia

Outcome Measures

Primary Outcomes (11)

• Changing of Pain after Wharton Jelly Originated Mesenchial Stem Cell İnjection for one year

  Pain Evaluation With Visual Analog Scale (min : 0 - max: 10)

  Before injection and 15 Day - 30 Day - 45 Day - 3 months - 6 Months - 12 Months after injection

• Changing of functional knee score after Wharton Jelly Originated Mesenchial Stem Cell İnjection for one year

  The Western Ontario and McMaster Universities Arthritis Index (WOMAC) measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).

  Before injection and 15 Day - 30 Day - 45 Day - 3 months - 6 Months - 12 Months after injection

• Changing of life Quality after Wharton Jelly Originated Mesenchial Stem Cell İnjection for one year

  Short Form 36 (min :0 - max :100)

  Before injection and 15 Day - 30 Day - 45 Day - 3 months - 6 Months - 12 Months after injection

• Radiological Changings according to Kellgren-Lawrence classification systemafter Wharton Jelly Originated Mesenchial Stem Cell İnjection for one year

  Direct Graphy Kellgren-Lawrence classification (0-4) - (0 : Better)

  Before injection and 12 Months after injection

• Chondral and subchondral Changings after Wharton Jelly Originated Mesenchial Stem Cell İnjection for one year

  Magnetic Resosonans Imaging T2 mapping (msn): If an area have a value above 50/msn that will named as inflamated cartilage. This area's size and mean speed will be evaluated.

  Before injection and 12 Months after injection

• Changing of Leptin levels in sinovial fluid after Wharton Jelly Originated Mesenchial Stem Cell İnjection for one year

  Leptin levels in sinovial fluid (elisa)

  Before injection and 15 Day - 30 Day - 45 Day - 3 months - 6 Months - 12 Months after injection

• Changing of adiponectin levels in sinovial fluid after Wharton Jelly Originated Mesenchial Stem Cell İnjection for one year

  Adiponectin levels in sinovial fluid (elisa)

  Before injection and 15 Day - 30 Day - 45 Day - 3 months - 6 Months - 12 Months after injection

• Changing of tumor necrosing factor-α levels in sinovial fluid after Wharton Jelly Originated Mesenchial Stem Cell İnjection for one year

  tumor necrosing factor-α levels in sinovial fluid (elisa)

  Before injection and 15 Day - 30 Day - 45 Day - 3 months - 6 Months - 12 Months after injection

• Changing of resistin levels in sinovial fluid after Wharton Jelly Originated Mesenchial Stem Cell İnjection for one year

  Resistin levels in sinovial fluid (elisa)

  Before injection and 15 Day - 30 Day - 45 Day - 3 months - 6 Months - 12 Months after injection

• Changing of interleukin-6 levels in sinovial fluid after Wharton Jelly Originated Mesenchial Stem Cell İnjection for one year

  interleukin-6 levels in sinovial fluid (elisa)

  Before injection and 15 Day - 30 Day - 45 Day - 3 months - 6 Months - 12 Months after injection

• Changing of interleukin-1β levels in sinovial fluid after Wharton Jelly Originated Mesenchial Stem Cell İnjection for one year

  interleukin-1β levels in sinovial fluid

  Before injection and 15 Day - 30 Day - 45 Day - 3 months - 6 Months - 12 Months after injection

Study Arms (1)

Stem Cell Therapia Group

EXPERIMENTAL

A total of 11 patients with Kellgren-Lawrence grade II-III knee OA who were admitted to the outpatient clinic with knee pain and who had received conservative treatment for a period of 6 months and who had not benefited from it will be taken. Patients will be evaluated 7 (V1-7) during the study period. Patients who comply with the study criteria will be included in the study. The clinical, immunological and radiological efficacy of the treatment and clinical improvement will be evaluated in all follow-up patients at the beginning and at the beginning of the treatment.

Biological: Wharton Jelly Originated Mesencimal Stem Cell

Interventions

Wharton Jelly Originated Mesencimal Stem Cell BIOLOGICAL

In this study, the patient who has no systemic disease from Erciyes University, Obstetrics and Gynecology Department will be taken to the cord transport solution which will be medical waste after delivery. Samples for transport bacteriological tests from the transport solution to the laboratory shall be separated. They will be processed in a number of ways. The cells obtained will be administered intraarticularly at a dose of 1 x 100.000.000.

Stem Cell Therapia Group

Eligibility Criteria

• Age: 60 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Kellgren-Lawrence Grade II-III OA
• Between 60- 65 years old
• Those with chronic knee pain not undergoing 6 months of conservative treatment
• Body Mass Index: 25-30 kg / m2
• Patients who understand the content of the study
• Patients with written consent form

You may not qualify if:

• Patients with Diabetes Mellitus
• Patients with septic table
• Patients with bleeding diathesis
• Patients with HIV and Hepatitis
• Body Mass Index greater than 30 kg / m2 and lower than 25 kg / m2
• Those with congenital axis disorder
• Those with malignancy
• Immunosuppressive
• Lumbar pathological findings

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University Faculty of Medicine

Melikgazi, Kayseri, 38050, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• İbrahim Karaman, Asc.Prof

  TC Erciyes University

  STUDY DIRECTOR

Central Study Contacts

Ali E Günay, MD

CONTACT

+905556493401; alieraygunay@hotmail.com

Ali E Günay, MD

CONTACT

+903522076666; alieraygunay@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: TC Erciyes University - Scientific Researches Projects Support

Study Record Dates

• First Submitted: February 9, 2019
• First Posted: March 18, 2020
• Study Start: January 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: March 18, 2020

Record last verified: 2020-03

Locations

TU (1)