search
Back to results

WHARTON JELLY ORIGINATED MESENCHIAL STEM CELL in GONARTHROSIS (WHAMKO)

Primary Purpose

Stem Cell, Gonarthrosis

Status
Unknown status
Phase
Phase 2
Locations
Turkey
Study Type
Interventional
Intervention
Wharton Jelly Originated Mesencimal Stem Cell
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stem Cell focused on measuring Gonarthrosis, Degenerative Arthritis Treatment, Stem Cell Therapia

Eligibility Criteria

60 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Erciyes University Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stem Cell Therapia Group

Arm Description

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.

Outcomes

Primary Outcome Measures

Changing of Pain after Wharton Jelly Originated Mesenchial Stem Cell İnjection for one year
Pain Evaluation With Visual Analog Scale (min : 0 - max: 10)
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).
Changing of life Quality after Wharton Jelly Originated Mesenchial Stem Cell İnjection for one year
Short Form 36 (min :0 - max :100)
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)
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.
Changing of Leptin levels in sinovial fluid after Wharton Jelly Originated Mesenchial Stem Cell İnjection for one year
Leptin levels in sinovial fluid (elisa)
Changing of adiponectin levels in sinovial fluid after Wharton Jelly Originated Mesenchial Stem Cell İnjection for one year
Adiponectin levels in sinovial fluid (elisa)
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)
Changing of resistin levels in sinovial fluid after Wharton Jelly Originated Mesenchial Stem Cell İnjection for one year
Resistin levels in sinovial fluid (elisa)
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)
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

Secondary Outcome Measures

Full Information

First Posted
February 9, 2019
Last Updated
March 17, 2020
Sponsor
TC Erciyes University
search

1. Study Identification

Unique Protocol Identification Number
NCT04313894
Brief Title
WHARTON JELLY ORIGINATED MESENCHIAL STEM CELL in GONARTHROSIS
Acronym
WHAMKO
Official Title
THE EFFECTIVENESS of WHARTON JELLY ORIGINATED MESENCHIAL STEM CELL in TREATMENT of KNEE OSTEOARTHRITIS
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Osteoarthritis (OA) is a progressive disease characterized by degeneration of the articular cartilage, caused with the release of proinflammatory cytokines and metalloproteinases. Knee osteoarthritis is the most common form. OA accounts for about 2% of public health problems and leads to a reduction in production, resulting in indirect costs. Regardless of the etiology (age, trauma, overuse, autoimmune arthritis, infection, etc.), the recovery is very slow, the damage is not fully recovered, and the result is secondary fibrosis healing. Therefore, the degeneration process continues and no treatment modality does not completely eliminate this process. Various methods are used in the treatment of OA. The most commonly used of these methods are the physical and educational therapy offered by the American Society of Orthopedic Surgeons (AAOS), symptomatic treatment with acetaminophen and non-steroidal anti-inflammatory drugs, and steroid injection. In patients with end-stage OA who do not benefit from these treatment methods, total joint replacement is performed. Mesenchymal stem cells are multiple potent progenitor cells. In recent years, there have been promising developments in the treatment of patients who cannot be cured by stem cell therapy. Mesenchymal stem cells have been used in clinical and experimental animal studies due to their immunosuppressive effects, limited immunogenetic effects, their ability to be produced in culture and their multilevel structure. At the same time, studies have shown that mesenchymal stem cells have potential to differentiate into osteocytes, chondrocytes, muscle cells and nerve cells. Because of these features, mesenchymal stem cells have been used clinically for OA treatment. In addition, studies have shown that mesenchymal stem cells can be obtained from bone marrow, periosteum, trabecular bone, fat tissue, synovia, muscle tissue, milk tooth, umbilical cord and Wharton gel. Wharton gel is a mucous connective tissue in the umbilical cord and consists of myofibroblast-like stromal cells, collagen fibers, proteoglycans and hyaluronic acid. Because of these properties, it can be used as a source of stem cells. dipocytokines are cytokines secreted from adipose tissue and act as intercellular signal proteins. These cytokines include adipose tissue and cells nutrient uptake, regulation of energy balance, insulin activation, lipid and glucose metabolism, angiogenesis, regulation of blood pressure, coagulation, immunostimulation, pro-inflammatory and anti-inflammatory effects. Stem cell applications are now widely used in different tissues. In the recovery of chondral damage; Since cells have little capacity for regeneration and proliferation, stem cell derived differentiation is needed. In this study, it will be tried to show that chondral damage can be treated with wharton gel-derived stem cells.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stem Cell, Gonarthrosis
Keywords
Gonarthrosis, Degenerative Arthritis Treatment, Stem Cell Therapia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stem Cell Therapia Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Wharton Jelly Originated Mesencimal Stem Cell
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changing of Pain after Wharton Jelly Originated Mesenchial Stem Cell İnjection for one year
Description
Pain Evaluation With Visual Analog Scale (min : 0 - max: 10)
Time Frame
Before injection and 15 Day - 30 Day - 45 Day - 3 months - 6 Months - 12 Months after injection
Title
Changing of functional knee score after Wharton Jelly Originated Mesenchial Stem Cell İnjection for one year
Description
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).
Time Frame
Before injection and 15 Day - 30 Day - 45 Day - 3 months - 6 Months - 12 Months after injection
Title
Changing of life Quality after Wharton Jelly Originated Mesenchial Stem Cell İnjection for one year
Description
Short Form 36 (min :0 - max :100)
Time Frame
Before injection and 15 Day - 30 Day - 45 Day - 3 months - 6 Months - 12 Months after injection
Title
Radiological Changings according to Kellgren-Lawrence classification systemafter Wharton Jelly Originated Mesenchial Stem Cell İnjection for one year
Description
Direct Graphy Kellgren-Lawrence classification (0-4) - (0 : Better)
Time Frame
Before injection and 12 Months after injection
Title
Chondral and subchondral Changings after Wharton Jelly Originated Mesenchial Stem Cell İnjection for one year
Description
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.
Time Frame
Before injection and 12 Months after injection
Title
Changing of Leptin levels in sinovial fluid after Wharton Jelly Originated Mesenchial Stem Cell İnjection for one year
Description
Leptin levels in sinovial fluid (elisa)
Time Frame
Before injection and 15 Day - 30 Day - 45 Day - 3 months - 6 Months - 12 Months after injection
Title
Changing of adiponectin levels in sinovial fluid after Wharton Jelly Originated Mesenchial Stem Cell İnjection for one year
Description
Adiponectin levels in sinovial fluid (elisa)
Time Frame
Before injection and 15 Day - 30 Day - 45 Day - 3 months - 6 Months - 12 Months after injection
Title
Changing of tumor necrosing factor-α levels in sinovial fluid after Wharton Jelly Originated Mesenchial Stem Cell İnjection for one year
Description
tumor necrosing factor-α levels in sinovial fluid (elisa)
Time Frame
Before injection and 15 Day - 30 Day - 45 Day - 3 months - 6 Months - 12 Months after injection
Title
Changing of resistin levels in sinovial fluid after Wharton Jelly Originated Mesenchial Stem Cell İnjection for one year
Description
Resistin levels in sinovial fluid (elisa)
Time Frame
Before injection and 15 Day - 30 Day - 45 Day - 3 months - 6 Months - 12 Months after injection
Title
Changing of interleukin-6 levels in sinovial fluid after Wharton Jelly Originated Mesenchial Stem Cell İnjection for one year
Description
interleukin-6 levels in sinovial fluid (elisa)
Time Frame
Before injection and 15 Day - 30 Day - 45 Day - 3 months - 6 Months - 12 Months after injection
Title
Changing of interleukin-1β levels in sinovial fluid after Wharton Jelly Originated Mesenchial Stem Cell İnjection for one year
Description
interleukin-1β levels in sinovial fluid
Time Frame
Before injection and 15 Day - 30 Day - 45 Day - 3 months - 6 Months - 12 Months after injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali E Günay, MD
Phone
+905556493401
Email
alieraygunay@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ali E Günay, MD
Phone
+903522076666
Email
alieraygunay@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
İbrahim Karaman, Asc.Prof
Organizational Affiliation
TC Erciyes University
Official's Role
Study Director
Facility Information:
Facility Name
Erciyes University Faculty of Medicine
City
Melikgazi
State/Province
Kayseri
ZIP/Postal Code
38050
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Eray GUNAY, resisdent
Phone
+905556493401
Email
alieraygunay@hotmail.com
First Name & Middle Initial & Last Name & Degree
İbrahim KARAMAN, docent
Phone
05327183353
Email
drikaraman@gmail.com
First Name & Middle Initial & Last Name & Degree
Ahmet Güney, professor
First Name & Middle Initial & Last Name & Degree
Yusuf Özkul, professor
First Name & Middle Initial & Last Name & Degree
Mukerrem B Aycan, Assoc. prof
First Name & Middle Initial & Last Name & Degree
Eren Demirpolat, Assist. prof
First Name & Middle Initial & Last Name & Degree
Ali Eray Günay, Med. Doctor
First Name & Middle Initial & Last Name & Degree
İbrahim Karaman, Assoc prof
First Name & Middle Initial & Last Name & Degree
Zeynep B Gonen, Resident
First Name & Middle Initial & Last Name & Degree
Ebru Ozturk, Resident

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

WHARTON JELLY ORIGINATED MESENCHIAL STEM CELL in GONARTHROSIS

We'll reach out to this number within 24 hrs