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

Primary Purpose

Knee Osteoarthritis

Status

Unknown status

Phase

Phase 1

Locations

Ukraine

Study Type

Interventional

Intervention

Placenta-derived MMSCs

Bone marrow-derived MMSCs

Hyalgan 20 mg in 2 ML Prefilled Syringe

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring BM-MMSCs;, P-MMSCs;, Hyaluronic Acid

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.
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.

Sites / Locations

Institute of Cell TherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Hyaluronic Acid (HA) + P-MMSCs

Hyaluronic Acid (HA) + BM-MMSCs

Hyaluronic Acid (HA)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Treatment-related adverse events

Secondary Outcome Measures

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.

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

Change in cartilage thickness of the knee using MRI

Quality of Life (QOL) assessment

Change in scores on the QOL

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).

Full Information

NCT ID

NCT04453111

First Posted

June 15, 2020

Last Updated

July 1, 2020

Sponsor

Institute of Cell Therapy

Collaborators

The Institute of Traumatology and Orthopedics of NAMS of Ukraine, Kyiv City Clinical Hospital № 6

1. Study Identification

Unique Protocol Identification Number

NCT04453111

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

January 2, 2020 (Actual)

Primary Completion Date

August 2021 (Anticipated)

Study Completion Date

October 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institute of Cell Therapy

Collaborators

The Institute of Traumatology and Orthopedics of NAMS of Ukraine, Kyiv City Clinical Hospital № 6

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

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)

Allocation

Non-Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hyaluronic Acid (HA) + P-MMSCs

Arm Type

Experimental

Arm Description

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

Arm Title

Hyaluronic Acid (HA) + BM-MMSCs

Arm Type

Experimental

Arm Description

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

Arm Title

Hyaluronic Acid (HA)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Placenta-derived MMSCs

Other Intervention Name(s)

P-MMSCs

Intervention Description

Cryopreserved placenta-derived multipotent mesenchymal stem / stromal cells

Intervention Type

Biological

Intervention Name(s)

Bone marrow-derived MMSCs

Other Intervention Name(s)

BM-MMSCs

Intervention Description

Cryopreserved bone marrow-derived multipotent mesenchymal stem / stromal cells

Intervention Type

Drug

Intervention Name(s)

Hyalgan 20 mg in 2 ML Prefilled Syringe

Other Intervention Name(s)

Intervention Description

Hyaluronic Acid 20 mg

Primary Outcome Measure Information:

Title

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

Description

Treatment-related adverse events

Time Frame

12 months

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

12 months.

Title

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

Description

Change in cartilage thickness of the knee using MRI

Time Frame

12 months

Title

Quality of Life (QOL) assessment

Description

Change in scores on the QOL

Time Frame

12 months

Title

The Visual Analog Scale (VAS) assessment

Description

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

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Peter Nemtinov, MD

Phone

+380442079207

nemtinov@stemcellclinic.com

First Name & Middle Initial & Last Name or Official Title & Degree

Vitalii Kyryk, MD, PhD

Phone

+380442079207

kyryk@stemcellclinic.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Nemtinov, MD

Organizational Affiliation

Institute of Cell Therapy

Official's Role

Study Director

Facility Information:

Facility Name

Institute of Cell Therapy

City

Kyiv

ZIP/Postal Code

04073

Country

Ukraine

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peter Nemtinov, MD

Phone

+380442079207

nemtinov@stemcellclinic.com

First Name & Middle Initial & Last Name & Degree

Vitalii Kyryk, PhD

Phone

+380442079207

kyryk@stemcellclinic.com

First Name & Middle Initial & Last Name & Degree

Evgen Goliuk, MD, PhD

First Name & Middle Initial & Last Name & Degree

Roman Birsa, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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