Mesenchymal stromal cells

National Research Center for Hematology, Russia · FDA-approved active Biologic

Mesenchymal stromal cells is a Cell therapy Biologic drug developed by National Research Center for Hematology, Russia. It is currently FDA-approved for Graft-versus-host disease (GVHD), Acute myocardial infarction, Osteoarthritis. Also known as: MSC, bone marrow derived mesenchymal stromal cells, TC-MSC, Allogeneic Cellular Therapy (NEPHSTROM ORBCEL-M).

Mesenchymal stromal cells (MSCs) are bone marrow-derived multipotent cells that exert immunomodulatory and tissue-regenerative effects through paracrine signaling and direct cell-cell interactions.

Mesenchymal stromal cells (MSCs) are multipotent bone marrow-derived cells that exert immunomodulatory and tissue-regenerative effects through paracrine signaling and direct cell-cell interactions. Used for Graft-versus-host disease (GVHD), Acute myocardial infarction, Tissue repair and regeneration.

At a glance

Generic name	Mesenchymal stromal cells
Also known as	MSC, bone marrow derived mesenchymal stromal cells, TC-MSC, Allogeneic Cellular Therapy (NEPHSTROM ORBCEL-M), Bone marrow derived mesenchymal stromal cells
Sponsor	National Research Center for Hematology, Russia
Drug class	Cell therapy
Modality	Biologic
Therapeutic area	Immunology, Regenerative Medicine
Phase	FDA-approved

Mechanism of action

MSCs secrete anti-inflammatory cytokines (IL-10, TGF-β) and growth factors that suppress pathogenic immune responses and promote tissue repair. They can differentiate into multiple cell types (osteocytes, chondrocytes, adipocytes) and home to damaged tissues, facilitating regeneration and reducing inflammation in autoimmune and degenerative conditions.

Approved indications

• Graft-versus-host disease (GVHD)
• Acute myocardial infarction
• Osteoarthritis
• Systemic lupus erythematosus

Common side effects

• Infusion reactions
• Fever
• Infection risk
• Immunogenicity

Key clinical trials

• A Trial to Evaluate the Safety and Preliminary Efficacy of iMesenchymal Stromal Cells(iMSC) in Subjects With SR-aGVHD (NA)
• Safety and Efficacy of Mesenchymal Stromal Cells (Amimestrocel ) in Diabetic Kidney Disease (PHASE2)
• Anterior Cruciate Ligament (ACL) Reconstruction With Autologous Fat Pad Derived Mesenchymal Stem Cells (PHASE1)
• Autologous SVF Therapy for Type 2 Diabetes (NA)
• Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis (PHASE3)
• Double-blind, Randomized, Controlled Clinical Trial to Assess Efficacy of MSC in Patients With COVID-19 ARDS (PHASE2)
• Intrathecal Autologous Adipose-derived Mesenchymal Stromal Cells for Amyotrophic Lateral Sclerosis (ALS) (PHASE2)
• Safety and Efficacy Study of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis in Patients With End-Stage Diabetic Kidney Disease (PHASE1, PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Mesenchymal stromal cells CI brief — competitive landscape report
• Mesenchymal stromal cells updates RSS · CI watch RSS
• National Research Center for Hematology, Russia portfolio CI

Frequently asked questions about Mesenchymal stromal cells

What is Mesenchymal stromal cells?

Mesenchymal stromal cells is a Cell therapy drug developed by National Research Center for Hematology, Russia, indicated for Graft-versus-host disease (GVHD), Acute myocardial infarction, Osteoarthritis.

How does Mesenchymal stromal cells work?

Mesenchymal stromal cells (MSCs) are bone marrow-derived multipotent cells that exert immunomodulatory and tissue-regenerative effects through paracrine signaling and direct cell-cell interactions.

What is Mesenchymal stromal cells used for?

Mesenchymal stromal cells is indicated for Graft-versus-host disease (GVHD), Acute myocardial infarction, Osteoarthritis, Systemic lupus erythematosus.

Who makes Mesenchymal stromal cells?

Mesenchymal stromal cells is developed and marketed by National Research Center for Hematology, Russia (see full National Research Center for Hematology, Russia pipeline at /company/national-research-center-for-hematology-russia).

Is Mesenchymal stromal cells also known as anything else?

Mesenchymal stromal cells is also known as MSC, bone marrow derived mesenchymal stromal cells, TC-MSC, Allogeneic Cellular Therapy (NEPHSTROM ORBCEL-M), Bone marrow derived mesenchymal stromal cells.

What drug class is Mesenchymal stromal cells in?

Mesenchymal stromal cells belongs to the Cell therapy class. See all Cell therapy drugs at /class/cell-therapy.

What development phase is Mesenchymal stromal cells in?

Mesenchymal stromal cells is FDA-approved (marketed).

What are the side effects of Mesenchymal stromal cells?

Common side effects of Mesenchymal stromal cells include Infusion reactions, Fever, Infection risk, Immunogenicity.

Related

• Drug class: All Cell therapy drugs
• Manufacturer: National Research Center for Hematology, Russia — full pipeline
• Therapeutic area: All drugs in Immunology, Regenerative Medicine
• Indication: Drugs for Graft-versus-host disease (GVHD)
• Indication: Drugs for Acute myocardial infarction
• Indication: Drugs for Osteoarthritis
• Also known as: MSC, bone marrow derived mesenchymal stromal cells, TC-MSC, Allogeneic Cellular Therapy (NEPHSTROM ORBCEL-M), Bone marrow derived mesenchymal stromal cells