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

NCT04453111 | Unknown Phase 1 DMC

• 1 other identifier: #7/09.26.2018
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis

Keywords

BM-MMSCs;; P-MMSCs;; Hyaluronic Acid

Outcome Measures

Primary Outcomes (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

  12 months

Secondary Outcomes (4)

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

  12 months.

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

  12 months

• Quality of Life (QOL) assessment

  12 months

• The Visual Analog Scale (VAS) assessment

  12 months

Study Arms (3)

Hyaluronic Acid (HA) + P-MMSCs

EXPERIMENTAL

Experimental 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

Biological: Placenta-derived MMSCs; Drug: Hyalgan 20 mg in 2 ML Prefilled Syringe

Hyaluronic Acid (HA) + BM-MMSCs

EXPERIMENTAL

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

Biological: Bone marrow-derived MMSCs; Drug: Hyalgan 20 mg in 2 ML Prefilled Syringe

Hyaluronic Acid (HA)

ACTIVE COMPARATOR

Three intra-articular injection of 20 mg Hyaluronic Acid - 15 patients

Drug: Hyalgan 20 mg in 2 ML Prefilled Syringe

Interventions

Placenta-derived MMSCs BIOLOGICAL

Cryopreserved placenta-derived multipotent mesenchymal stem / stromal cells

Also known as: P-MMSCs

Hyaluronic Acid (HA) + P-MMSCs

Bone marrow-derived MMSCs BIOLOGICAL

Cryopreserved bone marrow-derived multipotent mesenchymal stem / stromal cells

Also known as: BM-MMSCs

Hyaluronic Acid (HA) + BM-MMSCs

Hyalgan 20 mg in 2 ML Prefilled Syringe DRUG

Hyaluronic Acid 20 mg

Also known as: HA

Hyaluronic Acid (HA); Hyaluronic Acid (HA) + BM-MMSCs; Hyaluronic Acid (HA) + P-MMSCs

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Institute of Cell Therapy: lead
• The Institute of Traumatology and Orthopedics of NAMS of Ukraine: collaborator
• Kyiv City Clinical Hospital № 6: collaborator

Study Sites (1)

Institute of Cell Therapy

Kyiv, 04073, Ukraine

RECRUITING

Related Publications (1)

• 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.

  PMID: 40281581 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Peter Nemtinov, MD

  Institute of Cell Therapy

  STUDY DIRECTOR

Central Study Contacts

Peter Nemtinov, MD

CONTACT

+380442079207; nemtinov@stemcellclinic.com

Vitalii Kyryk, MD, PhD

CONTACT

+380442079207; kyryk@stemcellclinic.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: July 1, 2020
• Study Start: January 2, 2020
• Primary Completion: August 1, 2021
• Study Completion: October 1, 2021
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)