Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 60Years
All Genders
Healthy Volunteers
NCT06981741

Safety and Efficacy of hUC-MSC for the Treatment of Cartilage Damage in the Knee Joint

Led by BIONCaRT GmbH · Updated on 2026-01-13

55

Participants Needed

7

Research Sites

155 weeks

Total Duration

On this page

Sponsors

B

BIONCaRT GmbH

Lead Sponsor

K

KKS Netzwerk

Collaborating Sponsor

AI-Summary

What this Trial Is About

Testing the safety and efficacy of MSC from umbilical cord tissue (UC-MSC) for the treatment of cartilage damage in the knee joint

CONDITIONS

Official Title

Safety and Efficacy of hUC-MSC for the Treatment of Cartilage Damage in the Knee Joint

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 to 60 years
  • Clinical indication for surgical cartilage regeneration
  • Symptomatic grade III/IV cartilage defect or osteochondral defect with max depth 3 mm
  • Cartilage defect size 2-6 cm² on femoral condyles, patella, or trochlea
  • Kellgren-Lawrence osteoarthritis grade less than III in affected and contralateral knee
  • KOOS pain sub-score ≤ 70 in affected knee and > 80 in contralateral knee without analgesics in last 24 hours
  • Body mass index (BMI) under 35 kg/m²
  • Written informed consent including understanding of alternative treatments
Not Eligible

You will not qualify if you...

  • Indication for cartilage regeneration other than study treatment
  • Varus or valgus malalignment of affected leg ≥ 5°
  • Antero-posterior or medio-lateral knee instability
  • Meniscus loss > 20% in affected compartment
  • Patella instability
  • Simultaneous surgery on other joint structures
  • Higher-grade cartilage damage on corresponding joint surfaces (kissing lesions)
  • Osteoarthritis Kellgren-Lawrence grade III or IV
  • Arthrofibrosis
  • Metabolic arthropathy
  • Collagenosis
  • Autoimmune disease
  • Tumor disease within last 5 years
  • Neuromuscular disease
  • Peripheral arterial occlusive disease
  • Intra-articular treatment with hyaluronic acid, glucocorticoids, or platelet concentrates within last 6 months
  • Joint replacement in contralateral knee or hip within last 12 months
  • Rheumatoid arthritis or other inflammatory diseases
  • Previous fracture in affected knee
  • Osteoporosis
  • Contraindications to general anesthesia
  • Secondary diseases increasing surgery risk (cardiac insufficiency, coronary heart disease, coagulation disorders, diabetes, liver cirrhosis, renal insufficiency)
  • Known hypersensitivity to porcine collagens, human albumin, glucose, or fibrin adhesive components
  • Participation in another interventional clinical trial within last 4 weeks
  • Addiction or illnesses affecting consent capacity
  • Likely inability to adhere to protocol
  • Institutionalization by court or official order
  • Dependency on the sponsor
  • Pregnant or breastfeeding women
  • Women of childbearing age except those post-menopausal, post-operative bilateral ovariectomy, or using effective contraception or abstinence

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

Klinikum Altenburger Land, Klinik für Orthopädie und Unfallchirurgie

Altenburg, Germany, 04600

Actively Recruiting

2

St. Nikolaus Stifts-Hospital

Andernach, Germany, 56626

Actively Recruiting

3

Sozialstiftung Bamberg Klinikum am Bruderwald, Klinik für Orthopädie und Unfallchirurgie

Bamberg, Germany, 96049

Actively Recruiting

4

Evangelisches Waldkrankenhaus Spandau

Berlin, Germany, 13589

Actively Recruiting

5

GFO Kliniken Niederrhein, St. Vinzenz Hospital Dinslaken

Dinslaken, Germany, 46535

Actively Recruiting

6

UniversitätsCentrum für Orthopädie, Unfall- & Plastische Chirurgie, Universitätsklinikum Carl Gustav Carus an der TU Dresden

Dresden, Germany, 01307

Actively Recruiting

7

Maria-Josef-Hospital Greven, Klinik für Unfallchirurgie und Orthopädie

Greven, Germany, 48268

Actively Recruiting

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Research Team

K

Kristina Thamm, PhD

CONTACT

H

Heike Opitz, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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