Stem CellPhase 2WHAMKONCT04313894
WHARTON JELLY ORIGINATED MESENCHIAL STEM CELL in GONARTHROSIS
A Phase 2 study testing Wharton Jelly Originated Mesencimal Stem Cell in people with Stem Cell and Gonarthrosis, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 65 years
- Conditions the study is for
- Stem Cell, Gonarthrosis
- What is being tested?
- Wharton Jelly Originated Mesencimal Stem Cell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 31 Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Those with malignancy
- Immunosuppressive
- Lumbar pathological findings
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erciyes University Faculty of Medicine
Melikgazi, Kayseri, 38050
Ali Eray GUNAY, resisdent, +905556493401, alieraygunay@hotmail.com
İbrahim KARAMAN, docent, 05327183353, drikaraman@gmail.com
About this study
Official title: THE EFFECTIVENESS of WHARTON JELLY ORIGINATED MESENCHIAL STEM CELL in TREATMENT of KNEE OSTEOARTHRITIS
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.
Read the 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.
- Conditions
- Stem Cell, Gonarthrosis
- Being tested
- Wharton Jelly Originated Mesencimal Stem Cell
- Keywords
- Gonarthrosis, Degenerative Arthritis Treatment, Stem Cell Therapia
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wharton Jelly Originated Mesencimal Stem CellBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Wharton Jelly Originated Mesencimal Stem Cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changing of Pain after Wharton Jelly Originated Mesenchial Stem Cell İnjection for one year
Pain Evaluation With Visual Analog Scale (min : 0 - max: 10)
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: Before injection and 15 Day - 30 Day - 45 Day - 3 months - 6 Months - 12 Months after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start1 Jan 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem CellStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İbrahim Karaman, TC Erciyes University
- Investigators
- İbrahim Karaman, Asc.Prof, Study director, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313894
- Sponsor's protocol ID
- 2015/397
- Acronym
- WHAMKO
- Status last verified
- Mar 2020
- First submitted
- 9 Feb 2019
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECTIVENESS of WHARTON JELLY ORIGINATED MESENCHIAL STEM CELL in TREATMENT of KNEE OSTEOARTHRITIS
- ClinicalTrials.gov ID
- NCT04313894
- Acronym / sponsor ID
- WHAMKO / 2015/397
- Conditions
- Stem Cell, Gonarthrosis
- Keywords
- Gonarthrosis, Degenerative Arthritis Treatment, Stem Cell Therapia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 18 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stem Cell Therapia Group | Experimental | Biological: Wharton Jelly Originated Mesencimal Stem CellA 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. |
Who may qualify
- Ages
- 60 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wharton Jelly Originated Mesencimal Stem CellIn 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. | Biological | Stem Cell Therapia Group |
Primary outcome
Changing of Pain after Wharton Jelly Originated Mesenchial Stem Cell İnjection for one year
Time frame: Before injection and 15 Day - 30 Day - 45 Day - 3 months - 6 Months - 12 Months after injection
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
Time frame: Before injection and 15 Day - 30 Day - 45 Day - 3 months - 6 Months - 12 Months after injection
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
Time frame: Before injection and 15 Day - 30 Day - 45 Day - 3 months - 6 Months - 12 Months after injection
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
Time frame: Before injection and 12 Months after injection
Direct Graphy Kellgren-Lawrence classification (0-4) - (0 : Better)
Chondral and subchondral Changings after Wharton Jelly Originated Mesenchial Stem Cell İnjection for one year
Time frame: Before injection and 12 Months after injection
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
Time frame: Before injection and 15 Day - 30 Day - 45 Day - 3 months - 6 Months - 12 Months after injection
Leptin levels in sinovial fluid (elisa)
Changing of adiponectin levels in sinovial fluid after Wharton Jelly Originated Mesenchial Stem Cell İnjection for one year
Time frame: Before injection and 15 Day - 30 Day - 45 Day - 3 months - 6 Months - 12 Months after injection
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
Time frame: Before injection and 15 Day - 30 Day - 45 Day - 3 months - 6 Months - 12 Months after injection
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
Time frame: Before injection and 15 Day - 30 Day - 45 Day - 3 months - 6 Months - 12 Months after injection
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
Time frame: Before injection and 15 Day - 30 Day - 45 Day - 3 months - 6 Months - 12 Months after injection
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
Time frame: Before injection and 15 Day - 30 Day - 45 Day - 3 months - 6 Months - 12 Months after injection
interleukin-1β levels in sinovial fluid
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İbrahim Karaman, Asc.Prof study director
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Wharton Jelly Originated Mesencimal Stem Cell in people with Stem Cell and Gonarthrosis, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali E Günay, MD (+905556493401, alieraygunay@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changing of Pain after Wharton Jelly Originated Mesenchial Stem Cell İnjection for one year (time frame: Before injection and 15 Day - 30 Day - 45 Day - 3 months - 6 Months - 12 Months after injection). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.