Chronic Meniscal InjuryPhase 1/2NCT02033525
Mesenchymal Stromal Cells for Degenerative Meniscus Injury
A Phase 1/2 study testing XCEL-M-ALPHA and standard rehabilitation and Rehabilitation in people with Chronic Meniscal Injury, run by Banc de Sang i Teixits at 1 site in Spain.
Trial summary
The present proposal has the objective to assess whether the addition of autologous ex vivo expanded mesenchymal stromal cells (XCEL-M-ALPHA) to the conventional meniscal injury rehabilitation program is contributing in creating the proper healing environment for the meniscus repair. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Chronic Meniscal Injury
- What is being tested?
- XCEL-M-ALPHA and standard rehabilitation and Rehabilitation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 31 Jan 2014to 2 May 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient between 40 and 60 years of age
- Degenerative meniscus injury grade 3 (Crues et al.)
- Indication of conservative treatment
- Normal alignment of the knee (between 3º varus and 10 º valgus)
- Patient is able to follow a rehabilitation program
- Informed consent given by the patient in writing
- Patient is able to understand the trial.
Who cannot join
- Traumatic meniscus injury
- Surgical intervention to the affected knee
- Local or systemic infection
- Intraarticular treatment of the affected knee with steroids or hyaluronic acid within the past 3 months
- Significant abnormal laboratory tests that contraindicates participation in the trial.
- Pregnant women or intend to become pregnant or breast-feeding
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- Neoplastic process within the previous 5 years or without complete remission.
- The patient is wearing a pacemaker, allergy to contrast, severe renal insufficiency or any other condition that contraindicates the magnetic resonance using contrast.
- Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
- Legally dependant patient.
- The patient does not accept to be followed-up for a period that could exceed the clinical trial length
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I-IIa Safety and Efficacy Pilot Clinical Trial of Intraarticular Administration of Autologous Mesenchymal Cells for Meniscus Injury
The present proposal has the objective to assess whether the addition of autologous ex vivo expanded mesenchymal stromal cells (XCEL-M-ALPHA) to the conventional meniscal injury rehabilitation program is contributing in creating the proper healing environment for the meniscus repair. For this purpose, 20 patients will be randomized (10 per group) to one of the two treatment arms (rehabilitation + xcel-m-alpha or rehabilitation alone) . The conduction of this clinical trial will, in addition of having the aim of improving the patient's quality of life, contribute to consolidate an emerging new type of therapy which is still under development.
Read the detailed description
This is a prospective, unicentric, randomized, open-label, single-dose, two-arm, blinded assessor pilot study in which 20 patients with degenerative meniscus injury grade 3 (Crues et al.) will enter the study with the primary objective of assessing the efficacy of the treatment by VAS of pain at 12 month. Secondary objectives are to evaluate the safety and efficacy through imaging procedures and clinical questionnaires (IKDC, KOOS, Lysholm and SF-36.
Patients will be randomized to one of the two treatment arms (XCEL-M-ALPHA and standard rehabilitation program or standard rehabilitation program alone). Thereafter, patients will be followed for 12 months.
Imaging assessment will be performed by an independent blinded radiologist.
- Conditions
- Chronic Meniscal Injury
- Being tested
- XCEL-M-ALPHA and standard rehabilitation, Rehabilitation
- Keywords
- Chronic Meniscal Injury, Degenerative meniscus, Meniscus injury, Meniscal injury, Mesenchymal stromal cells, Mesenchymal stem cells, Advanced Therapy, Bone marrow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XCEL-M-ALPHA and standard rehabilitationDrug
Also called XCEL-M-ALPHA
Intraarticular infusion of autologous bone marrow derived ex vivo expanded mesenchymal stromal cells produced at Xcelia (Advanced Therapies Division of the Blood and Tissue Bank)
RehabilitationOther
Standard rehabilitation program
| Study group | Role | What they receive |
|---|---|---|
| XCEL-M-ALPHA and standard rehabilitation | Experimental | Intraarticular administration of XCEL-M-ALPHA followed by standard rehabilitation program Receives: Drug: XCEL-M-ALPHA and standard rehabilitation |
| standard rehabilitation | Active comparator | Standard rehabilitation program Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS for pain
Visual analogue scale (VAS) for pain at 12 month follow-up.
Measured: 12 month
Secondary outcomes (4)
Safety
Safety will be assessed by collecting adverse events, physical exam, laboratory tests, and vital signs.
Measured: 12 month
Efficacy by MRI
Efficacy will be assessed by qualitative and quantitative changes of the meniscus and articular cartilage by imaging procedures (MRI) at 6 and 12 month follow-up.
Measured: 6 and 12 month
VAS for pain
Visual analogue scale (VAS) for pain at 1, 3 and 6 month follow-up.
Measured: 1, 3 and 6 month
Efficacy by clinical questionnaires
IKDC, KOOS and Lysholm functionality test and SF-36 quality of life at 3, 6 and 12 month follow-up
Measured: 3, 6 and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study start31 Jan 2014
- Primary completion2 May 2017
- Study completion2 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Meniscal InjuryStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Banc de Sang i Teixits
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitari Quirón Dexeus, Ministerio de Sanidad, Servicios Sociales e Igualdad
- Responsible party
- Sponsor
- Investigators
- Joan Carles Monllau, MD, PhD, Principal investigator, ICATME-Hospital Quiron Dexeus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033525
- Sponsor's protocol ID
- XCEL-MEN-01
- Other IDs
- 2011-006270-13
- Status last verified
- Jan 2018
- First submitted
- 8 Jan 2014
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I-IIa Safety and Efficacy Pilot Clinical Trial of Intraarticular Administration of Autologous Mesenchymal Cells for Meniscus Injury
- ClinicalTrials.gov ID
- NCT02033525
- Acronym / sponsor ID
- XCEL-MEN-01
- Conditions
- Chronic Meniscal Injury
- Keywords
- Chronic Meniscal Injury, Degenerative meniscus, Meniscus injury, Meniscal injury, Mesenchymal stromal cells, Mesenchymal stem cells, Advanced Therapy, Bone marrow
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Banc de Sang i TeixitsUniversity, hospital or other
- Collaborators
- Hospital Universitari Quirón Dexeus, Ministerio de Sanidad, Servicios Sociales e Igualdad
- Study start
- 31 Jan 2014 (actual)
- Primary completion
- 2 May 2017 (actual)
- Study completion
- 2 May 2017 (actual)
- First posted
- 10 Jan 2014 (estimated)
- 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 present proposal has the objective to assess whether the addition of autologous ex vivo expanded mesenchymal stromal cells (XCEL-M-ALPHA) to the conventional meniscal injury rehabilitation program is contributing in creating the proper healing environment for the meniscus repair. For this purpose, 20 patients will be randomized (10 per group) to one of the two treatment arms (rehabilitation + xcel-m-alpha or rehabilitation alone) . The conduction of this clinical trial will, in addition of having the aim of improving the patient's quality of life, contribute to consolidate an emerging new type of therapy which is still under development.
Detailed description
This is a prospective, unicentric, randomized, open-label, single-dose, two-arm, blinded assessor pilot study in which 20 patients with degenerative meniscus injury grade 3 (Crues et al.) will enter the study with the primary objective of assessing the efficacy of the treatment by VAS of pain at 12 month. Secondary objectives are to evaluate the safety and efficacy through imaging procedures and clinical questionnaires (IKDC, KOOS, Lysholm and SF-36.
Patients will be randomized to one of the two treatment arms (XCEL-M-ALPHA and standard rehabilitation program or standard rehabilitation program alone). Thereafter, patients will be followed for 12 months.
Imaging assessment will be performed by an independent blinded radiologist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XCEL-M-ALPHA and standard rehabilitation | Experimental | Drug: XCEL-M-ALPHA and standard rehabilitationIntraarticular administration of XCEL-M-ALPHA followed by standard rehabilitation program |
| standard rehabilitation | Active comparator | Other: RehabilitationStandard rehabilitation program |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patient between 40 and 60 years of age
- Degenerative meniscus injury grade 3 (Crues et al.)
- Indication of conservative treatment
- Normal alignment of the knee (between 3º varus and 10 º valgus)
- Patient is able to follow a rehabilitation program
Key exclusion criteria (11 listed)
- Traumatic meniscus injury
- Surgical intervention to the affected knee
- Local or systemic infection
- Intraarticular treatment of the affected knee with steroids or hyaluronic acid within the past 3 months
- Significant abnormal laboratory tests that contraindicates participation in the trial.
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 |
|---|---|---|
| XCEL-M-ALPHA and standard rehabilitationAlso: XCEL-M-ALPHAIntraarticular infusion of autologous bone marrow derived ex vivo expanded mesenchymal stromal cells produced at Xcelia (Advanced Therapies Division of the Blood and Tissue Bank) | Drug | XCEL-M-ALPHA and standard rehabilitation |
| RehabilitationStandard rehabilitation program | Other | standard rehabilitation |
Primary outcome
VAS for pain
Time frame: 12 month
Visual analogue scale (VAS) for pain at 12 month follow-up.
4 secondary outcomes
Safety
Time frame: 12 month
Efficacy by MRI
Time frame: 6 and 12 month
VAS for pain
Time frame: 1, 3 and 6 month
Efficacy by clinical questionnaires
Time frame: 3, 6 and 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Fundación ICATME (Spanish only)Link provided by the sponsor.
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.
Joan Carles Monllau, MD, PhD principal investigator
ICATME-Hospital Quiron Dexeus
1 site 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 XCEL-M-ALPHA and standard rehabilitation and Rehabilitation in people with Chronic Meniscal Injury, run by Banc de Sang i Teixits at 1 site in Spain.
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 7 inclusion and 11 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: finished, as of the sponsor's last update on 9 Jan 2018. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
VAS for pain (time frame: 12 month). 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 9 Jan 2018.