AzTrials
AzTrials

Knee OsteoarthritisPhase 1/2NCT04453111

Efficacy of Bone-marrow-derived and Placenta-derived Multipotent Mesenchymal Stem / Stromal Cells for Osteoarthritis

A Phase 1/2 study testing Placenta-derived MMSCs, Bone marrow-derived MMSCs and Hyalgan 20 mg in 2 ML Prefilled Syringe in people with Knee Osteoarthritis, run by Institute of Cell Therapy at 1 site in Ukraine.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To define the clinical effects of intra-articular transplantation of bone-marrow-derived (BM-MMSCs) and placenta-derived multipotent mesenchymal stem / stromal cells (P-MMSCs) for knee osteoarthritis. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Placenta-derived MMSCs, Bone marrow-derived MMSCs and Hyalgan 20 mg in 2 ML Prefilled Syringe
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteUkraine
Study dates
2 Jan 2020to Oct 2021
Phase
Phase 1/2
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of knee osteoarthritis.
  • Age: 18 to 75 years old.
  • Kellgren-Lawrence Grade 2 or 3 according to X-ray imaging.
  • Knee pain.
  • Written informed consent

Who cannot join

  • Age <18 or >75 years of age by time of infusion.
  • Participation in an on-going investigational therapeutic or device trial 30 days of consent.
  • Rheumatoid arthritis.
  • Psoriatic arthritis.
  • Juvenile idiopathic arthritis.
  • Gout.
Show all 36Show fewer
  • Infectious arthritis.
  • Osteomyelitis.
  • Osteonecrosis.
  • Inflammatory arthritis.
  • Chondropathy.
  • Joint contracture.
  • Arthroplasty.
  • Arthroscopy within 6 months prior to study entry.
  • Intra-articular injection within 3 months prior to study entry.
  • Hormone intake.
  • Antiaggregants and anticoagulants intake.
  • Immunosuppressants intake.
  • Allergy to hyaluronic acid.
  • History of organ or cell transplantation.
  • Hematologic abnormality evidenced by hematocrit < 25%, white blood cell < 2,500/ul or platelet count < 100,000/ul.
  • Active infection.
  • Positive for HIV antigen.
  • History of hepatitis B, hepatitis C.
  • History of malignancy in the last 5 years prior to study entry.
  • Active tumors.
  • History of myocardial infarction.
  • History of stroke.
  • Renal failure with chronic hemodialysis.
  • Liver Cirrhosis (ICGR 15 >30%).
  • Chromosomal abnormality.
  • Peripheral nervous system disorders.
  • Cognitive or language barriers that prohibit obtaining informed consent or any study elements.
  • History of drug abuse or alcohol abuse, or documented medical, occupational, or legal problems arising from the use of alcohol or drugs within the past 24 months.
  • Pregnant/nursing women or women of child-bearing potential.
  • Other condition that limits lifespan to < 1 year.

Trial locations and contacts

1 site in 1 country.

Peter Nemtinov, MD contact

+380442079207

nemtinov@stemcellclinic.com

Vitalii Kyryk, MD, PhD contact

+380442079207

kyryk@stemcellclinic.com

Ukraine1 site, 1 recruiting

  • Institute of Cell Therapy

    Kyiv, 04073

    Peter Nemtinov, MD, +380442079207, nemtinov@stemcellclinic.com

    Vitalii Kyryk, PhD, +380442079207, kyryk@stemcellclinic.com

    Recruiting

Other trials in Ukraine

About this study

To define the clinical effects of intra-articular transplantation of bone-marrow-derived (BM-MMSCs) and placenta-derived multipotent mesenchymal stem / stromal cells (P-MMSCs) for knee osteoarthritis.

Read the detailed description

Multipotent mesenchymal stem / stromal cells (MMSCs) of different origin are the novel therapeutic agents that can slow down cartilage degeneration, improve reparation and ultimately prevent joint prosthetics. MSCs are capable to direct differentiation into chondrocytes, produce cytokines and growth factors with immunomodulatory and anti-inflammatory effects, stimulate angiogenesis, as well as induce chemotaxis of endogenous progenitors. Bone marrow-derived and placenta-derived MMSCs can be considered the most promising source for cell therapy of joints disorders according to availability, safety and expected therapeutic efficacy.

Being tested
Placenta-derived MMSCs, Bone marrow-derived MMSCs, Hyalgan 20 mg in 2 ML Prefilled Syringe
Keywords
BM-MMSCs;, P-MMSCs;, Hyaluronic Acid
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placenta-derived MMSCsBiological

    Also called P-MMSCs

    Cryopreserved placenta-derived multipotent mesenchymal stem / stromal cells

  • Bone marrow-derived MMSCsBiological

    Also called BM-MMSCs

    Cryopreserved bone marrow-derived multipotent mesenchymal stem / stromal cells

  • Hyalgan 20 mg in 2 ML Prefilled SyringeDrug

    Also called HA

    Hyaluronic Acid 20 mg

Study groups in NCT04453111
Study groupRoleWhat they receive
Hyaluronic Acid (HA) + P-MMSCsExperimentalExperimental Group 1: Three intra-articular injection of allogeneic P-MMSCs up to 2•107cells (target dose up to 6•107 cells) with 20 mg Hyaluronic Acid at 4-weeks intervals - 15 patients
Receives: Biological: Placenta-derived MMSCs; Drug: Hyalgan 20 mg in 2 ML Prefilled Syringe
Hyaluronic Acid (HA) + BM-MMSCsExperimentalExperimental Group 2: Three intra-articular injection of autologous BM-MMSCs up to 2•107cells (target dose up to 6•107 cells) with 20 mg Hyaluronic Acid at 4-weeks intervals - 15 patients
Receives: Biological: Bone marrow-derived MMSCs; Drug: Hyalgan 20 mg in 2 ML Prefilled Syringe
Hyaluronic Acid (HA)Active comparatorThree intra-articular injection of 20 mg Hyaluronic Acid - 15 patients
Receives: Drug: Hyalgan 20 mg in 2 ML Prefilled Syringe

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with adverse events and changes in physical examinations, vital signs and the results of clinical lab tests.

    Treatment-related adverse events

    Measured: 12 months

Secondary outcomes (4)

  1. Physical function improvement measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC).

    Change in joint function from baseline WOMAC assessment. The WOMAC used a scoring scale of 0-4 (lower scores indicate lower levels of symptoms or physical disability). The higher the score, the higher the amount of pain, stiffness, and a high level of functional limitations.

    Measured: 12 months.

  2. Radiographic evidence. Whole-Organ Magnetic Resonance Imaging Score (WORMS)

    Change in cartilage thickness of the knee using MRI

    Measured: 12 months

  3. Quality of Life (QOL) assessment

    Change in scores on the QOL

    Measured: 12 months

  4. The Visual Analog Scale (VAS) assessment

    VAS - measure of pain intensity. The scale is most commonly anchored by "no pain " (score of 0) and "worst imaginable pain" (score of 10).

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2020
  2. Study start2 Jan 2020
  3. Primary completionAug 2021 (estimated)
  4. Study completionOct 2021 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Experimental: HA + stem cells therapy Experimental Group 1: three intra-articular injection of allogeneic P-MMSCs with up to 2•107cells (target dose up to 6•107 cells) with 20 mg Hyaluronic Acid at 4-weeks intervals - 15 patients Experimental Group 2: three intra-articular injection of autologous BM-MMSCs up to 2•107cells (target dose up to 6•107 cells) with 20 mg Hyaluronic Acid at 4-weeks intervals - 15 patients Control Group: three intra-articular injection of 20 mg Hyaluronic Acid, no cell therapy - 15 patients
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04453111
Sponsor's protocol ID
#7/09.26.2018
Status last verified
Jul 2020
First submitted
15 Jun 2020
Last updated
7 Jul 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Holiuk Y, Birsa R, Bukreieva T, Nemtinov P, Kyryk V, Ustymenko A, Mazevych V, Sokolov M, Lobyntseva G, Shablii V. Effectiveness and safety of multiple injections of human placenta-derived MSCs for knee osteoarthritis: a nonrandomized phase I trial. BMC Musculoskelet Disord. 2025 Apr 26;26(1):418. doi: 10.1186/s12891-025-08664-2.

    PubMed 40281581

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Placenta-derived MMSCs, Bone marrow-derived MMSCs and Hyalgan 20 mg in 2 ML Prefilled Syringe in people with Knee Osteoarthritis, run by Institute of Cell Therapy at 1 site in Ukraine.

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 5 inclusion and 36 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 7 Jul 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 Ukraine. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Peter Nemtinov, MD (+380442079207, nemtinov@stemcellclinic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events and changes in physical examinations, vital signs and the results of clinical lab tests. (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04453111, which also lists 1 linked publication.

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 7 Jul 2020.

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