Clinical Evidence

How We Support Clinical Care

At TAVRA Biosciences, we focus on defined clinical areas where regenerative therapies may support localized tissue health, function, and recovery. Published clinical literature examining bone marrow–derived mesenchymal stromal cells across joint, soft-tissue, and disc settings emphasizes favorable safety profiles and reports statistically significant reductions in pain and improvements in function. 

Contact us for additional Clinical Evidence for complete study design, dosing details, and all citations for mesenchymal stem cell therapy applications.

Click on any icon for more information.

Safety

Based on evidence from more than 100 randomized controlled trials and multiple high-quality systematic reviews and meta-analyses involving over 5,000 patients, locally administered MSC therapy has demonstrated a strong safety profile and meaningful therapeutic benefit across several indications. The most commonly reported adverse event, transient fever, is generally self-limiting and
manageable.

TAVRA builds on this intrinsic safety profile through donor eligibility and screening, validated manufacturing processes, defined xeno-free culture conditions, and a DMSO-free product formulation designed to support safety, consistency, and product quality.

Knee: Advanced Recovery for Osteoarthritis & Injury

BM-MSCs have the most developed clinical evidence base in knee applications, spanning stem cell injections for knee pain, osteoarthritis, cartilage injury, and ligament repair.

Study

Design

Key Finding

Gupta 2023 (AJSM)

  • Phase 3 RCT
  • 146 patients
  • Allogeneic BM-MSC 25M cells

45.6% improvement in WOMAC at 12 months (p<0.001). MRI showed cartilage preservation in MSC group vs progressive worsening in placebo.

Vega 2015 (Transplantation)

  • RCT
  • 30 patients
  • Allogeneic BM-MSC 40M cells
Off-the-shelf BM-MSCs vs hyaluronic acid: significant improvement in pain, function, and cartilage quality on quantitative MRI.

Forsythe 2022 (Arthroscopy)

  • Level 1 RCT
  • 80 patients
  • BMAC ~2.5 mL

BMAC augmentation of ACL reconstruction: accelerated ligamentization on MRI at 3 months; higher IKDC scores at 9 months (81.6 vs 74.6, p=0.048).

Shoulder: Long-Term Structural Integrity

The shoulder evidence base is anchored by one of the most compelling long-term datasets in regenerative orthopedics.

Study

Design

Key Finding

Hernigou 2014 (Int Orthop)

  • Case-controlled, 10-year follow-up
  • 90 patients
  • BMAC

100% healing at 6 months vs 67% in controls; 87% structural integrity at 10 years vs 44%. Higher MSC count correlated with better outcomes.

Cole 2023 (AJSM)

  • Level 1 RCT
  • 91 patients
  • BMAC ~2.5 mL

BMAC-augmented rotator cuff repair: retear rate 18% vs 57% (p<0.001). Structurally superior repair confirmed on imaging.

Centeno 2024 (BMC MSK)

  • RCT, 2-year follow-up
  • 51 patients
  • BMAC

Percutaneous BMAC vs. home exercise: significantly greater improvement in NPS (pain), DASH, and SANE scores at every time interval through 24 months. 73% of BMC patients showed radiographic improvement on imaging.

Back and Spine: Regenerative Solutions for Pain

Back and spine carries the strongest allogeneic evidence outside of knee OA, including the only published allogeneic BM-MSC RCT for disc disease and a 100-patient controlled dataset with 36-month durability.

Study

Design

Key Finding

Noriega 2017 (Transplantation)

  • RCT, 24 patients
  • Allogeneic BM-MSC 25M cells (single intradiscal injection)

Rapid, significant improvement in pain and disability; Pfirrmann grading improved in MSC group vs worsened in controls at 12 months; 40% were strong responders; no immune reactions

Amirdelfan 2021 (Spine J)

  • Multicenter RCT, 100 patients, 36-month follow-up
  • Allogeneic MPCs 6M or 18M cells + HA
Significant superiority in VAS and ODI at multiple time points through 36 months; well tolerated with no immune reactions; largest controlled dataset for allogeneic cell therapy in DDD

Pettine 2015/2016 (Stem Cells / Int Orthop)

  • Prospective, 26 patients, 2-year follow-up
  • BMAC
71% VAS reduction and >64% ODI improvement at 24 months; 81% avoided surgery through 2 years; 40% improved ≥1 Pfirrmann grade on MRI

Hip: Cartilage Repair & Pain Reduction

The hip evidence base draws on BMAC surgical adjunct data, with clinical findings supporting MSC therapy in cartilage repair and pain reduction contexts.

Study

Design

Key Finding

Martin 2025 (JBJS)

  • Prospective cohort, 81 hips, 5-year follow-up
  • BMAC

BMAC-augmented labral repair: significantly higher mHHS, iHOT-33, and HOS-SS at 60 months vs no-BMAC controls; differences emerged at 24 months and increased in magnitude through 5 years

Martin 2022(JBJS)

  • Prospective cohort, 124 patients, 2-year follow-up
  • BMAC
Patients with moderate cartilage damage (Outerbridge 2–3) derived significantly greater benefit from BMAC augmentation (iHOT-33: 82.5 vs 69.5 at 24 months, p=0.030); sicker joints respond more to MSC therapy

Entessari 2023 (Regen Med)

  • Narrative review, 6 clinical studies
  • Mix of MSC sources

5/6 studies showed statistically significant improvement in PROs after MSC injection for hip OA; no major complications; positive radiological changes in 2 studies

Allogeneic vs. Autologous Considerations

Most of the foundational BMAC literature uses variable, point-of-care preparations where MSC content is not standardized and donor age is the patient’s own. Allogeneic BM-MSCs differ in two clinically relevant ways. First, they deliver a defined, consistent cell dose across treatments. Second, preclinical data indicates that MSCs from younger donors demonstrate superior proliferative capacity and paracrine function compared to cells from older donors, which is relevant when treating patients whose autologous cell quality and potency are likely diminished. These considerations are reflected in how the supporting BMAC evidence should be interpreted when evaluating allogeneic products.

Request Information or Initiate an Order