Cartilage DefectPhase 1NCT05553132
A Study of REcycled CartiLage Auto/Allo IMplantation to Treat and Repair Focal Hip Cartilage Defects
A Phase 1 study testing Autologous Chondrocytes in their Pericellular Matrix (Chondrons) Coimplanted with Allogeneic Adipose-Derived Mesenchymal Stromal Cells (AMSCs) in a Fibrin Glue Carrier in people with Cartilage Defect, run by Daniel B. F. Saris at 1 site in United States.
Trial summary
The purpose of this research study it to gather information on the safety and side effects of treating cartilage defects with autologous cartilage cells mixed with allogeneic adipose-derived mesenchymal stem cells (AMSCs) in a fibrin glue. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cartilage Defect
- What is being tested?
- Autologous Chondrocytes in their Pericellular Matrix (Chondrons) Coimplanted with Allogeneic Adipose-Derived Mesenchymal Stromal Cells (AMSCs) in a Fibrin Glue Carrier
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2023to Dec 2026
- Phase
- Phase 1
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Persons of childbearing potential must have a negative pregnancy test prior to receiving the study drug and will agree to use adequate contraception (hormonal or barrier method or abstinence) at the time of screening. Females of childbearing potential are defined as premenopausal and not surgically sterilized, or post-menopausal for fewer than 2 years. A urine pregnancy test will be performed prior to the administration of the study drug to confirm negative results. If the urine pregnancy test is positive, the study drug will not be administered, and the result will be confirmed by a serum pregnancy test. Urine pregnancy tests will be performed by qualified personnel using kit. Persons becoming pregnant during the study will continue to be monitored for the duration of the study or completion of the pregnancy, whichever is longer. Monitoring will include perinatal and neonatal outcome. Any SAEs associated with pregnancy will be recorded.
- Chronic (> 3 months), unilaterally symptomatic, ICRS Grade III or IV cartilage lesions ranging in size from 2 to 6 cm2. Patients with episodes of contralateral hip pain that is asymptomatic at the time of enrollment will be eligible for inclusion. However, patients with previous episodes of contralateral hip pain who experience a repeat episode of contralateral pain similar to their established pattern of pain during the course of the trial will not be considered as having experienced an adverse event.
- Radiographic hip OA of Tönnis Grade 1 or less, consisting of normal hip radiographs (Grade 0) or doubtful narrowing of the joint space and possible osteophytic lipping (Grade 1) as agreed upon by two study co-investigators without underlying structural hip abnormalities
- Previous 6 week or longer trial of one of the following conservative treatments: activity modification, weight loss, physical therapy, anti-inflammatory medications, or injection therapy (e.g. cortisone). An adequate trial will consist of pursuance and reasonable execution (i.e. > 80% medication or therapy compliance) of medically reasonable course of non-operative modalities with minimal to no improvements in symptoms
- If applicable, at least 3 months will have passed since the last target hip intraarticular injection prior to undergoing the RECLAIM procedure and at least 6 months will have passed between any prior arthroscopic or open hip procedures.
- Able to routinely walk without assistance (e.g. cane, walker)
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- Clinically stable target hip.
- No additional surgery planned in the target hip for at least 12 months following the RECLAIM procedure
- Completed general physical and well-being evaluation with primary care provider within 12 months of enrollment
- Fully understanding of the requirements of the study and willingness to comply with the treatment plan, including laboratory tests, diagnostic imaging, and follow-up visits and assessments
- Can provide written informed consent and complete HIPAA documentation after the nature of the study is fully explained and prior to any study-related procedure
Who cannot join
- Pregnant or nursing, or planning on becoming pregnant during the study period
- Congenital or acquired malformation of the target hip resulting in significant deformity or leading to problems with the study treatment or analysis of the results
- Significant structural deformity, including large cam lesion (alpha angle greater than 55 degrees) or moderate dysplasia (defined as lateral center edge angle less than 18 degrees).
- Injections of any kind into the target hip within 3 months prior to study enrollment
- History of intra-articular infection in the target hip
- History of superficial infection in the target hip within 6 months of study enrollment, or evidence of current superficial infection affecting the target hip
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- History of falls requiring medical attention, or gait instability
- Clinically significant abnormal hematology (complete blood count with differential), blood chemistry, or urinalysis screening laboratory results. Absolute cutoffs for exclusion include hemoglobin < 11 g / dL, platelets < 110,000 platelets / mL, and an INR greater than 1.3.
- Body mass index (BMI) > 35 kg/m2
- Tönnis Grade II or greater on X-Ray.
- Taking anticoagulant medications (e.g. warfarin, heparin or clopidogrel) which may pose a clinically significant contraindication to the surgical RECLAIM procedure
- Taking herbal therapies or supplements within 4 weeks of enrollment or unwilling to avoid use of herbal therapies or supplements until study completion (includes, but not limited to chondroitin sulfate, diacerein, n-glucosamine, piascledine, and capsaicin)
- Taking non-steroidal anti-inflammatory medications (e.g. COX-2 inhibitors) without a stable dosing regimen for at least 4 weeks before baseline evaluation, or anticipating not remaining on a stable dose until study completion
- On chronic, immunosuppressive transplant therapy or having a chronic, immunosuppressive state, including use of systemic steroids/corticosteroids
- Current tobacco product use, including nicotine patch or other nicotine products
- Clinically significant rheumatological or inflammatory disease of the hip or chondrocalcinosis/calcium pyrophosphate disease (CPPD), hemochromatosis, inflammatory arthritis, arthropathy of the hip associated with juxta-articular Paget's disease of the femur or pelvis, ochronosis, hemophilic arthropathy, infectious arthritis, Charcot's hip joint, villonodular synovitis, and synovial chondromatosis
- Ongoing infectious disease, including but not limited to tuberculosis, HIV, hepatitis, and syphilis
- Clinically significant cardiovascular (e.g. history of myocardial infarction, congestive heart failure or uncontrolled hypertension), neurologic (e.g. stroke, TIA) renal, hepatic, orthopedic (e.g. surgery on other weight bearing joints that will interfere with study, osteoporosis, acute lower body fractures), or endocrine disease (e.g. diabetes).
- Any clinically significant comorbidity affecting the patient's ability to undergo surgery
- Vascular or neurological disorder affecting the either lower limb which poses clinical significance to the safety of the operative RECLAIM procedure.
- History of cancer/malignancy with the exception of adequately treated basal cell or squamous cell carcinoma of the skin not associated with the target knee
- History of clinically significant blood dyscrasia, including but not limited to anemia, thrombocytopenia, and monoclonal gammopathy
- Participation in a study of an experimental drug or medical device within 3 months of study enrollment
- Known allergy to local anesthetics or other components of the study drug. This includes known allergy or contraindications to products of bovine origin (including aprotinin) or hypersensitivity to antibiotics, if the latter are used in the manufacturing process
- Any contraindication to MRI scan according to MRI guidelines, or unwillingness to undergo MRI procedures
- Any illness or condition which, in the investigators' judgement will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
- History of coagulopathy, including bleeding diathesis and deep venous thrombosis/pulmonary embolism.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hip RECLAIM: A Phase I Safety and Feasibility Trial of REcycled CartiLage Auto/Allo IMplantation for the Treatment and Repair of Focal Hip Cartilage Defects
The purpose of this research study it to gather information on the safety and side effects of treating cartilage defects with autologous cartilage cells mixed with allogeneic adipose-derived mesenchymal stem cells (AMSCs) in a fibrin glue.
- Conditions
- Cartilage Defect
- Being tested
- Autologous Chondrocytes in their Pericellular Matrix (Chondrons) Coimplanted with Allogeneic Adipose-Derived Mesenchymal Stromal Cells (AMSCs) in a Fibrin Glue Carrier
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Chondrocytes in their Pericellular Matrix (Chondrons) Coimplanted with Allogeneic Adipose-Derived Mesenchymal Stromal Cells (AMSCs) in a Fibrin Glue CarrierCombination product
Cartilage cells are being used from the rim of the defect in the hip and recycled to help make new cartilage in the hip. There are not enough cartilage cells to fill the defect so cartilage cells need to be mixed with MSCs. MSCs or Mesenchymal Stem Cells are naturally occurring cells that provide growth factors and cell signals that play a role in tissue repair. MSCs can be found in bone marrow and in the fatty tissues (i.e., area under the skin of the belly or breast) of patients. Fibrin glue is a product made from the naturally occurring compounds in blood which cause clotting. This glue hardens into a gel-like substance into which cells such as cartilage cells (chondrons) and AMSCs can be placed.
| Study group | Role | What they receive |
|---|---|---|
| CartiLage Auto/Allo IMplantation for Focal Hip Cartilage Defects | Experimental | Subject will receive the combined product of autologous cartilage cells and allogeneic AMSCs in a fibrin glue carrier. Receives: Combination Product: Autologous Chondrocytes in their Pericellular Matrix (Chondrons) Coimplanted with Allogeneic Adipose-Derived Mesenchymal Stromal Cells (AMSCs) in a Fibrin Glue Carrier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Number of adverse events defined as any untoward or undesirable medical occurrence in the form of signs, symptoms, abnormal findings, or diseases that emerge or worsen relative to baseline (i.e., if present upon study entry) during the study regardless of causal relationship.
Measured: 2 years
Incidence of serious adverse events (SAEs)
Number of SAEs as defined as AEs that result in death, life threatening adverse experiences, hospitalization, new or prolonged disability/incapacity, persistent or significant congenital defect/anomaly, or other events that in the opinion of the PI may have adversely affected the rights, safety, or welfare of the subjects or others, or substantially compromised the research data.
Measured: 2 years
Secondary outcomes (3)
Change in pain
Measured using self-reported 10 mm VAS
Measured: Baseline, 1-2 weeks, 6 weeks, 12 weeks, 24 weeks, 52 weeks, 18 months, and 24 months post-treatment
Change in physical function
Measured using the PROMIS-CAT-Physical Function assessment with questions to evaluate self-reported physical function on a scale of 5 to 1, with higher scores indicating better outcomes.
Measured: Baseline, 1-2 weeks, 6 weeks, 12 weeks, 24 weeks, 52 weeks, 18 months, and 24 months post-treatment
Change in hip function
Measured using the International Hip Outcome Tool (IHOT12). 12-item self-reported questionnaire assessing function of hip on a scale of 0 to 10, with higher outcomes indicating worse outcomes
Measured: Baseline, 1-2 weeks, 6 weeks, 12 weeks, 24 weeks, 52 weeks, 18 months, and 24 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start8 Aug 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage DefectStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daniel B. F. Saris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniel B. F. Saris, Mayo Clinic
- Investigators
- Aaron Krych, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553132
- Sponsor's protocol ID
- 22-004639
- Status last verified
- Feb 2026
- First submitted
- 21 Sep 2022
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hip RECLAIM: A Phase I Safety and Feasibility Trial of REcycled CartiLage Auto/Allo IMplantation for the Treatment and Repair of Focal Hip Cartilage Defects
- ClinicalTrials.gov ID
- NCT05553132
- Acronym / sponsor ID
- 22-004639
- Conditions
- Cartilage Defect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Daniel B. F. SarisUniversity, hospital or other
- Study start
- 8 Aug 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Sep 2022 (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.
The purpose of this research study it to gather information on the safety and side effects of treating cartilage defects with autologous cartilage cells mixed with allogeneic adipose-derived mesenchymal stem cells (AMSCs) in a fibrin glue.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CartiLage Auto/Allo IMplantation for Focal Hip Cartilage Defects | Experimental | Combination Product: Autologous Chondrocytes in their Pericellular Matrix (Chondrons) Coimplanted with Allogeneic Adipose-Derived Mesenchymal Stromal Cells (AMSCs) in a Fibrin Glue CarrierSubject will receive the combined product of autologous cartilage cells and allogeneic AMSCs in a fibrin glue carrier. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Persons of childbearing potential must have a negative pregnancy test prior to receiving the study drug and will agree to use adequate contraception (hormonal or barrier method or abstinence) at the time of screening. Females of childbearing potential are defined as premenopausal and not surgically sterilized, or post-menopausal for fewer than 2 years. A urine pregnancy test will be performed prior to the administration of the study drug to confirm negative results. If the urine pregnancy test is positive, the study drug will not be administered, and the result will be confirmed by a serum pregnancy test. Urine pregnancy tests will be performed by qualified personnel using kit. Persons becoming pregnant during the study will continue to be monitored for the duration of the study or completion of the pregnancy, whichever is longer. Monitoring will include perinatal and neonatal outcome. Any SAEs associated with pregnancy will be recorded.
- Chronic (> 3 months), unilaterally symptomatic, ICRS Grade III or IV cartilage lesions ranging in size from 2 to 6 cm2. Patients with episodes of contralateral hip pain that is asymptomatic at the time of enrollment will be eligible for inclusion. However, patients with previous episodes of contralateral hip pain who experience a repeat episode of contralateral pain similar to their established pattern of pain during the course of the trial will not be considered as having experienced an adverse event.
- Radiographic hip OA of Tönnis Grade 1 or less, consisting of normal hip radiographs (Grade 0) or doubtful narrowing of the joint space and possible osteophytic lipping (Grade 1) as agreed upon by two study co-investigators without underlying structural hip abnormalities
- Previous 6 week or longer trial of one of the following conservative treatments: activity modification, weight loss, physical therapy, anti-inflammatory medications, or injection therapy (e.g. cortisone). An adequate trial will consist of pursuance and reasonable execution (i.e. > 80% medication or therapy compliance) of medically reasonable course of non-operative modalities with minimal to no improvements in symptoms
- If applicable, at least 3 months will have passed since the last target hip intraarticular injection prior to undergoing the RECLAIM procedure and at least 6 months will have passed between any prior arthroscopic or open hip procedures.
Key exclusion criteria (27 listed)
- Pregnant or nursing, or planning on becoming pregnant during the study period
- Congenital or acquired malformation of the target hip resulting in significant deformity or leading to problems with the study treatment or analysis of the results
- Significant structural deformity, including large cam lesion (alpha angle greater than 55 degrees) or moderate dysplasia (defined as lateral center edge angle less than 18 degrees).
- Injections of any kind into the target hip within 3 months prior to study enrollment
- History of intra-articular infection in the target hip
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 |
|---|---|---|
| Autologous Chondrocytes in their Pericellular Matrix (Chondrons) Coimplanted with Allogeneic Adipose-Derived Mesenchymal Stromal Cells (AMSCs) in a Fibrin Glue CarrierCartilage cells are being used from the rim of the defect in the hip and recycled to help make new cartilage in the hip. There are not enough cartilage cells to fill the defect so cartilage cells need to be mixed with MSCs. MSCs or Mesenchymal Stem Cells are naturally occurring cells that provide growth factors and cell signals that play a role in tissue repair. MSCs can be found in bone marrow and in the fatty tissues (i.e., area under the skin of the belly or breast) of patients. Fibrin glue is a product made from the naturally occurring compounds in blood which cause clotting. This glue hardens into a gel-like substance into which cells such as cartilage cells (chondrons) and AMSCs can be placed. | Combination product | CartiLage Auto/Allo IMplantation for Focal Hip Cartilage Defects |
Primary outcome
Incidence of Adverse Events
Time frame: 2 years
Number of adverse events defined as any untoward or undesirable medical occurrence in the form of signs, symptoms, abnormal findings, or diseases that emerge or worsen relative to baseline (i.e., if present upon study entry) during the study regardless of causal relationship.
Incidence of serious adverse events (SAEs)
Time frame: 2 years
Number of SAEs as defined as AEs that result in death, life threatening adverse experiences, hospitalization, new or prolonged disability/incapacity, persistent or significant congenital defect/anomaly, or other events that in the opinion of the PI may have adversely affected the rights, safety, or welfare of the subjects or others, or substantially compromised the research data.
3 secondary outcomes
Change in pain
Time frame: Baseline, 1-2 weeks, 6 weeks, 12 weeks, 24 weeks, 52 weeks, 18 months, and 24 months post-treatment
Change in physical function
Time frame: Baseline, 1-2 weeks, 6 weeks, 12 weeks, 24 weeks, 52 weeks, 18 months, and 24 months post-treatment
Change in hip function
Time frame: Baseline, 1-2 weeks, 6 weeks, 12 weeks, 24 weeks, 52 weeks, 18 months, and 24 months post-treatment
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 5 Feb 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Aaron Krych, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous Chondrocytes in their Pericellular Matrix (Chondrons) Coimplanted with Allogeneic Adipose-Derived Mesenchymal Stromal Cells (AMSCs) in a Fibrin Glue Carrier in people with Cartilage Defect, run by Daniel B. F. Saris at 1 site in United States.
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 11 inclusion and 27 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: under way, not looking for participants, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (time frame: 2 years). The study lists 2 primary outcomes in all. 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 5 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.