Cartilage DamagePhase 1/2BPCC001NCT06981741
Safety and Efficacy of hUC-MSC for the Treatment of Cartilage Damage in the Knee Joint
A Phase 1/2 study testing BP CC 001 in people with Cartilage Damage, run by BIONCaRT GmbH at 7 sites in Germany.
Trial summary
Testing the safety and efficacy of MSC from umbilical cord tissue (UC-MSC) for the treatment of cartilage damage in the knee joint Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cartilage Damage
- What is being tested?
- BP CC 001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 7 sitesGermany
- Study dates
- 10 Nov 2025to Nov 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients of any gender with an age from ≥ 18 years to ≤ 60 years
- Clinical indication for a surgical cartilage regeneration procedure
- Symptomatic grade III/IV cartilage defect according to ICRS or osteochondral defect with a maximum depth of 3 mm
- A cartilage defect requiring treatment with a defect size of 2-6 cm² on the femoral condyles or patella or trochlea
- Affected and contralateral knee (if known): Kellgren-Lawrence (K/L) osteoarthritis severity < grade III
- KOOS pain sub-score of ≤ 70 (out of max. 100) in the affected knee joint and > 80 (out of max. 100) in the contralateral knee joint measured without taking analgesics within the last 24 hours
- BMI < 35 kg/m²
- Written informed consent of the participant, also regarding alternative procedures such as cartilage transplantation (MACT) or matrix-augmented bone marrow stimulation (BMS, AMIC)
Who cannot join
- Clinical indication explicitly for a cartilage regeneration procedure other than the intended study treatment
- Known varus or valgus malalignment of the affected leg of ≥ 5°
- Antero-posterior or medio-lateral instability
- Meniscus loss of more than 20% in the affected compartment
- Patella instability
- Simultaneous surgery on other joint structures (cruciate ligament replacement, meniscus suture, partial meniscus resection > 20%, osteotomy)
Show all 36Show fewer
- Simultaneous higher-grade (ICRS grade III/IV) cartilage damage on the corresponding joint surfaces to the treated cartilage damage ("kissing lesions")
- Osteoarthritis Kellgren-Lawrence (K/L) grade III or IV
- Arthrofibrosis
- Metabolic arthropathy
- Collagenosis
- Autoimmune disease
- Tumor disease within the last 5 years
- Neuromuscular disease
- Peripheral arterial occlusive disease
- Intra-articular application of hyaluronic acid or glucocorticoids or platelet concentrates within the last 6 months
- Joint replacement in the contra-lateral knee or hip within the last 12 months
- Rheumatoid arthritis or other inflammatory diseases such as autoimmune diseases, seronegative spondyloarthritis, gout, pseudogout
- Previous fracture in the affected knee joint
- Osteoporosis
- Contraindications against the planned operation under general anesthesia
- Relevant secondary diseases that increase the risk of surgery, e.g. cardiac insufficiency, coronary heart disease, coagulation disorders, diabetes mellitus, liver cirrhosis, renal insufficiency, etc.
- History of known hypersensitivity to porcine collagens, human albumin, glucose or components of fibrin adhesives used in orthopaedics or surgery
- Simultaneous participation in another interventional clinical trial (incl. within the last 4 weeks prior to inclusion)
- Addiction or other illnesses that do not allow the person concerned to assess the nature, scope and possible consequences of the clinical trial (lack of capacity to consent)
- Indications that the patient is unlikely to adhere to the protocol (e.g. lack of compliance)
- Persons who are placed in an institution by court or official order
- Persons who are dependent on the sponsor
- Pregnant or breastfeeding women
- Women of childbearing age, except women who meet the following criteria:
- Post-menopausal (12 months natural amenorrhea)
- Post-operative (6 weeks after bilateral ovariectomy with or without hysterectomy or bilateral salpingectomy)
- Presence of a negative pregnancy test (urine, not older than 14 days on the day of surgery) and willingness to regularly and correctly use a contraceptive method with a Pearl Index < 1 % per year:
- 3.1 Combined (oestrogen and progestogen-containing) hormonal contraception 3.2 Hormonal contraception containing progestogens (oral, injected, implanted) 3.3 IUD (hormonal IUD, copper IUD)
- Sexual abstinence
- Vasectomy of the partner
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Germany7 sites, 7 recruiting
- Recruiting
Klinikum Altenburger Land, Klinik für Orthopädie und Unfallchirurgie
Altenburg, 04600
- Recruiting
St. Nikolaus Stifts-Hospital
Andernach, 56626
- Recruiting
Sozialstiftung Bamberg Klinikum am Bruderwald, Klinik für Orthopädie und Unfallchirurgie
Bamberg, 96049
- Recruiting
Evangelisches Waldkrankenhaus Spandau
Berlin, 13589
- Recruiting
GFO Kliniken Niederrhein, St. Vinzenz Hospital Dinslaken
Dinslaken, 46535
- Recruiting
UniversitätsCentrum für Orthopädie, Unfall- & Plastische Chirurgie, Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden, 01307
- Recruiting
Maria-Josef-Hospital Greven, Klinik für Unfallchirurgie und Orthopädie
Greven, 48268
About this study
Official title: Phase I/IIa Study to Test the Safety and Efficacy of MSC From Umbilical Cord Tissue (UC-MSC) for the Treatment of Cartilage Damage in the Knee Joint
Testing the safety and efficacy of MSC from umbilical cord tissue (UC-MSC) for the treatment of cartilage damage in the knee joint
Read the detailed description
All patients who provide written informed consent after receiving detailed information about the study and its potential risks will undergo a screening to assess eligibility. This is a prospective, multicenter, single-arm, open-label clinical trial. On Visit 1 (Day 0), eligible patients will receive knee surgery with a one-time application of the investigational product to the cartilage defect. Follow-up visits over a two-year period will be conducted at regular intervals to monitor the safety of the investigational product and to collect initial data on its efficacy.
- Conditions
- Cartilage Damage
- Being tested
- BP CC 001
- Keywords
- knee, cartilage, mesenchymal stromal cells, mesenchymal stem cells, UC-MSC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BP CC 001Biological
10-20 x 10^6 UC-MSC in 1 ml suspension, applied to a collagen carrier structure (Chondro-Gide®)
| Study group | Role | What they receive |
|---|---|---|
| Investigational Product Arm | Experimental | Participants in this arm will undergo arthroscopic or minimally invasive knee surgery, during which the investigational product - mesenchymal stromal cells (MSCs) derived from umbilical cord tissue (MesemCart) - will be applied once directly to the cartilage defect. All patients will receive the same treatment and will be monitored for safety and initial efficacy outcomes over a period of 24 months. Receives: Biological: BP CC 001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a serious adverse event within 24 months after surgery
Measured: within 24 months after surgery
Secondary outcomes (7)
Regeneration of damaged cartilage measured using the MOCART score
The MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue) scoring system ranges from 0 to 100. A score of 0 indicates no repair, while 100 represents an excellent cartilage defect repair.
Measured: 12 months after surgery
Relative change in pain in the knee joint compared to the initial value before the operation measured using the KOOS Pain Subscore
The Knee Injury and Osteoarthritis Outcome Score (KOOS) ranges from 0 to 100, where 0 represents extreme knee problems and 100 represents no knee problems.
Measured: 12 and 24 months after the operation
Relative change in knee-related quality of life compared to pre-surgery baseline measured by KOOS-QoL subscore
The Knee Injury and Osteoarthritis Outcome Score (KOOS) ranges from 0 to 100, where 0 represents extreme knee problems and 100 represents no knee problems.
Measured: 12 and 24 months after surgery
Relative change in symptoms and stiffness compared to pre-surgery baseline as measured by KOOS symptom subscore
The Knee Injury and Osteoarthritis Outcome Score (KOOS) ranges from 0 to 100, where 0 represents extreme knee problems and 100 represents no knee problems.
Measured: 12 and 24 months after surgery
Relative change in activities of daily living compared to pre-surgery baseline measured by KOOS-ADL subscore
The Knee Injury and Osteoarthritis Outcome Score (KOOS) ranges from 0 to 100, where 0 represents extreme knee problems and 100 represents no knee problems.
Measured: 12 and 24 months after surgery
Relative change in physical resilience during sporting activities after the operation compared to the initial value before the operation measured using the KOOS-Sport/Rec-Subscore
The Knee Injury and Osteoarthritis Outcome Score (KOOS) ranges from 0 to 100, where 0 represents extreme knee problems and 100 represents no knee problems.
Measured: 12 and 24 months
Description of all adverse events (AE, AR, SAE, SAR, SUSAR) with regard to severity (assessed according to NCI-CTCAE V 5.0), causality, outcome
Measured: within 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start10 Nov 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage DamageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BIONCaRT GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KKS Netzwerk, Fraunhofer Institute for Cell Therapy and Immunology IZI, Polski Bank Komorek Macierzystych JSC (PBKM)
- Responsible party
- Sponsor
- Investigators
- Jörg Lützner, Prof.Dr.med., Principal investigator, UniversitätsCentrum für Orthopädie, Unfall- & Plastische Chirurgie, Universitätsklinikum Carl Gustav Carus, TU Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981741
- Sponsor's protocol ID
- MesemCart2Clinic - BP CC 001
- Other IDs
- 2024-517684-23-00
- Acronym
- BPCC001
- Status last verified
- Jan 2026
- First submitted
- 13 May 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/IIa Study to Test the Safety and Efficacy of MSC From Umbilical Cord Tissue (UC-MSC) for the Treatment of Cartilage Damage in the Knee Joint
- ClinicalTrials.gov ID
- NCT06981741
- Acronym / sponsor ID
- BPCC001 / MesemCart2Clinic - BP CC 001
- Conditions
- Cartilage Damage
- Keywords
- knee, cartilage, mesenchymal stromal cells, mesenchymal stem cells, UC-MSC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- BIONCaRT GmbHIndustry (pharma, biotech, devices)
- Collaborators
- KKS Netzwerk, Fraunhofer Institute for Cell Therapy and Immunology IZI, Polski Bank Komorek Macierzystych JSC (PBKM)
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Testing the safety and efficacy of MSC from umbilical cord tissue (UC-MSC) for the treatment of cartilage damage in the knee joint
Detailed description
All patients who provide written informed consent after receiving detailed information about the study and its potential risks will undergo a screening to assess eligibility. This is a prospective, multicenter, single-arm, open-label clinical trial. On Visit 1 (Day 0), eligible patients will receive knee surgery with a one-time application of the investigational product to the cartilage defect. Follow-up visits over a two-year period will be conducted at regular intervals to monitor the safety of the investigational product and to collect initial data on its efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational Product Arm | Experimental | Biological: BP CC 001Participants in this arm will undergo arthroscopic or minimally invasive knee surgery, during which the investigational product - mesenchymal stromal cells (MSCs) derived from umbilical cord tissue (MesemCart) - will be applied once directly to the cartilage defect. All patients will receive the same treatment and will be monitored for safety and initial efficacy outcomes over a period of 24 months. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients of any gender with an age from ≥ 18 years to ≤ 60 years
- Clinical indication for a surgical cartilage regeneration procedure
- Symptomatic grade III/IV cartilage defect according to ICRS or osteochondral defect with a maximum depth of 3 mm
- A cartilage defect requiring treatment with a defect size of 2-6 cm² on the femoral condyles or patella or trochlea
- Affected and contralateral knee (if known): Kellgren-Lawrence (K/L) osteoarthritis severity < grade III
Key exclusion criteria (36 listed)
- Clinical indication explicitly for a cartilage regeneration procedure other than the intended study treatment
- Known varus or valgus malalignment of the affected leg of ≥ 5°
- Antero-posterior or medio-lateral instability
- Meniscus loss of more than 20% in the affected compartment
- Patella instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BP CC 00110-20 x 10^6 UC-MSC in 1 ml suspension, applied to a collagen carrier structure (Chondro-Gide®) | Biological | Investigational Product Arm |
Primary outcome
Proportion of patients with a serious adverse event within 24 months after surgery
Time frame: within 24 months after surgery
7 secondary outcomes
Regeneration of damaged cartilage measured using the MOCART score
Time frame: 12 months after surgery
Relative change in pain in the knee joint compared to the initial value before the operation measured using the KOOS Pain Subscore
Time frame: 12 and 24 months after the operation
Relative change in knee-related quality of life compared to pre-surgery baseline measured by KOOS-QoL subscore
Time frame: 12 and 24 months after surgery
Relative change in symptoms and stiffness compared to pre-surgery baseline as measured by KOOS symptom subscore
Time frame: 12 and 24 months after surgery
Relative change in activities of daily living compared to pre-surgery baseline measured by KOOS-ADL subscore
Time frame: 12 and 24 months after surgery
Relative change in physical resilience during sporting activities after the operation compared to the initial value before the operation measured using the KOOS-Sport/Rec-Subscore
Time frame: 12 and 24 months
Description of all adverse events (AE, AR, SAE, SAR, SUSAR) with regard to severity (assessed according to NCI-CTCAE V 5.0), causality, outcome
Time frame: within 24 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jörg Lützner, Prof.Dr.med. principal investigator
UniversitätsCentrum für Orthopädie, Unfall- & Plastische Chirurgie, Universitätsklinikum Carl Gustav Carus, TU Dresden
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BP CC 001 in people with Cartilage Damage, run by BIONCaRT GmbH at 7 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristina Thamm, PhD (+491607697453, kristina.thamm@bioncart.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with a serious adverse event within 24 months after surgery (time frame: within 24 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.