Implantation of Allogenic Mesenchymal Stem Cell From Umbilical Cord Blood for Osteoarthritis Management
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ClinicalTrials.gov Identifier: NCT03800810 |
Recruitment Status : Unknown
Verified January 2019 by Ismail Hadisoebroto Dilogo, Indonesia University.
Recruitment status was: Recruiting
First Posted : January 11, 2019
Last Update Posted : January 23, 2019
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Condition or disease | Intervention/treatment | Phase |
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Osteoarthritis, Knee | Drug: Hyaluronic Acid Biological: Umbilical Cord Mesenchymal Stem Cell Biological: Recombinant Human Somatropin | Early Phase 1 |
This study is experimental clinical, randomized control trial. This study estimated time would be 24 months, from May 2016 until May 2018. Samples are obtained consecutively from all source population that meet criteria. This study divide the samples into three groups, synovial artificial group, MSC and synovial artificial combination group; MSC, Synovial, and recombinant human growth hormone group. The number of samples in each group is three.
Subject Criteria Inclusion Criteria for MSC Donor from Umbilical Cord:
Umbilical cord are collected from elective caesarean section from a fullterm pregnancies without any complication and free from HIV, Hepatitis B, C, D virus, Cytomegalovirus, Rubella Virus, and free from fungal and bacterial contamination.
Recipient inclusion criteria of osteoarthritis samples are patients aged 30-80 years old, based on genu X-ray examination and Kellgren-Lawrence grading is I, II, and III, or KL grade III with corrective osteotomy, minimal Visual Analog Scale = 2 (0-10), unresponsive with pharmacological therapy, and also sign up the informed consent.
Recipient exclusion criteria are Osteoarthritis KL grade IV, and secondary osteoarthritis due to trauma, infection, rheumatoid arthritis, congenital diseases, and autoimmune diseases, hypersensitivity of hyaluronan product, cancer, pregnant women.
Drop Out Criteria patients are ruled out from this study while the research are held or they undergo another treatment that are not related to this study. All drop out subjects could get another treatment.
Informed consent all of subjects must be filled and signed up before ruled in this study.
As soon as after delivery, umbilical cord is collected and processed in sterile specimen 0,9% NaCl at 4oC during 8 hours. The umbilical cord transported to the laboratory and cultured in GMP lab, at UPTTK Sel Punca Cipto Mangunkusumo Hospital. Cellular viability and proliferation are evaluated after cell characterization test by flowcytometer.
Sterility test are done three times to ensure cellular sterility. Subjects are positioned in supine position, site of injection are determined by the operator. Injection from superolateral or superomedial in extension knee position, injection from anterolateral or anteromedial in flexion knee position. Aseptic and antiseptic in site of injection use povidone iodine 3 times, then swab by alcohol. Local anesthetic by lidocaine 1% is injected subcutaneously.
Monitoring at the site of injection encompass allergic reaction, pain, and swelling. Patients are approached to be followed up every three months, in 1st ,3rd ,6th ,12th month, for clinical examination, VAS, IKDC and WOMAC Score. Cartigram MRI are evaluated every six month, in 6th and 12th month.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 9 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Potency of Allogenic Umbilical Cord Mesenchymal Stem Cells for Osteoarthritis Management |
Study Start Date : | May 2015 |
Estimated Primary Completion Date : | May 2019 |
Estimated Study Completion Date : | May 2019 |

Arm | Intervention/treatment |
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Experimental: Control
Week 1: Intraarticular injection of 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis) Week 2: Intraarticular injection of 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis) Week 3: Intraarticular injection of 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis)
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Drug: Hyaluronic Acid
Other Name: Hyaluronan |
Experimental: Intervention 1
Week 1: Intraarticular injection of 10x10^6 unit of umbilical cord mesenchymal stem cells in 2 ml conditioned medium, 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis) Week 2: Intraarticular injection of 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis), 8 IU recombinant human somatropin (Novell-Eutropin®, Novell Pharmaceutical Laboratories) Week 3: Intraarticular injection of 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis), 8 IU recombinant human somatropin (Novell-Eutropin®, Novell Pharmaceutical Laboratories)
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Drug: Hyaluronic Acid
Other Name: Hyaluronan Biological: Umbilical Cord Mesenchymal Stem Cell Biological: Recombinant Human Somatropin |
Experimental: Intervention 2
Week 1: Intraarticular injection of 10x10^6 unit of umbilical cord mesenchymal stem cells in 2 ml conditioned medium, 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis) Week 2: Intraarticular injection of 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis) Week 3: Intraarticular injection of 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis)
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Drug: Hyaluronic Acid
Other Name: Hyaluronan Biological: Umbilical Cord Mesenchymal Stem Cell |
Experimental: Intervention 3
Week 1: Intraarticular injection of 10x10^6 unit of umbilical cord mesenchymal stem cells in 2 ml conditioned medium, 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis) Week 2: Intraarticular injection of 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis), 8 IU recombinant human somatropin (Novell-Eutropin®, Novell Pharmaceutical Laboratories) Week 3: Intraarticular injection of 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis), 8 IU recombinant human somatropin (Novell-Eutropin®, Novell Pharmaceutical Laboratories)
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Drug: Hyaluronic Acid
Other Name: Hyaluronan Biological: Recombinant Human Somatropin |
- Cartilage T2 map score [ Time Frame: 6 months ]MRI examination of the knee with additional T2 mapping software CartiGram (GE Healthcare, USA). T2 map sequence are obtained from the medial and lateral aspect of both femoral and tibial cartilage.
- IKDC score [ Time Frame: 3 months ]
Subjective assessment of knee function using the International Knee Documentation Committee Subjective Knee Evaluation form.
Scale ranges from 1 to 100, higher value indicates higher function.
- WOMAC score [ Time Frame: 3 months ]
Subjective assessment of knee function using the the Western Ontario and McMaster Universities Osteoarthritis Index.
Scale ranges from 100% to 1%, lower value indicates higher function.
- VAS score [ Time Frame: 3 months ]VAS score is used to assess knee pain experienced by subjects.

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Ages Eligible for Study: | 30 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients aged 30-80 years old
- Kellgren-Lawrence grade I, II, and III, or KL grade III with corrective osteotomy according to knee x-ray examination
- Minimal VAS: 2
- Unresponsive with pharmacological therapy
- Signed the informed consent
Exclusion Criteria:
- Osteoarthritis KL grade IV
- Secondary osteoarthritis due to trauma, infection, rheumatoid arthritis, congenital diseases, autoimmune diseases
- Hypersensitivity to hyaluronic acid
- Malignancies (Previously or currently diagnosed)
- Pregnancy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03800810
Contact: Ismail H Dilogo, MD, PhD | +622144539917 | ismailorthofkui@yahoo.co.id | |
Contact: Tri Kurniawati, BSc | +622144539917 | selpuncarscm@yahoo.co.id |
Indonesia | |
Universitas Indonesia | Recruiting |
Jakarta Pusat, Jakarta, Indonesia, 10430 | |
Contact: Tri Kurniawati, BSc +622144539917 selpuncarscm@yahoo.co.id | |
Principal Investigator: Ismail H Dilogo, MD, PhD |
Publications:
Responsible Party: | Ismail Hadisoebroto Dilogo, Consultant, Department of Orthopaedics and Traumatology, Indonesia University |
ClinicalTrials.gov Identifier: | NCT03800810 |
Other Study ID Numbers: |
ISMMSCOA |
First Posted: | January 11, 2019 Key Record Dates |
Last Update Posted: | January 23, 2019 |
Last Verified: | January 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Name Gender Contact Address Sign up |
Osteoarthritis Mesenchymal Stem Cells Umbilical Cord |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Osteoarthritis Osteoarthritis, Knee Arthritis |
Hyaluronic Acid Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Viscosupplements Protective Agents |