Achilles Tendinitis, Right LegPhase 2ASCATNCT02064062
Autologous Stem Cells in Achilles Tendinopathy
A Phase 2 study testing Autologous Mesenchymal Stem Cells in people with Achilles Tendinitis, Right Leg and Achilles Tendinitis, run by University College, London at 1 site in United Kingdom.
Trial summary
This study is looking at a new treatment, using the patient's own stem cells (the repair cells of the body), to see whether this can help reduce pain and promote healing of the Achilles tendon, without side effects. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Achilles Tendinitis, Right Leg, Achilles Tendinitis, Achilles Degeneration
- What is being tested?
- Autologous Mesenchymal Stem Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2015to Dec 2018
- Phase
- Phase 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 and ≤ 70 (both males and females)
- Participants with chronic midportion AT (as defined by pain in region of AT and tender swelling in mid portion of AT (no tenderness over bony attachment to heel) with symptoms for longer than 6 months who have failed conservative treatment (at least a full course of physiotherapy) and for whom surgery is being considered
- Able to provide written informed consent
Who cannot join
- Previous bony surgery (e.g. reconstructive pelvic osteotomy) at or in proximity to the bone marrow harvest site
- Pregnancy or lactation
- Current use of steroids, anti-tumour necrosis factor (TNF) drugs, methotrexate, or ciprofloxacin (or use within 4 weeks of assessment for eligibility)
- Positive for hepatitis B virus (HBV), Hepatitis C virus (HCV), Human Immunodeficiency Virus (HIV 1 and 2), syphilis and human t-cell leukaemia virus (HTLV)
- Previous AT surgery on the tendon to receive mesenchymal stem cell (MSC) implantation
- Inflammatory arthritis
Show all 9Show fewer
- Known or suspected underlying haematological malignancy
- Other active malignancy in the past 3 years
- Bovine or antibiotic allergy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal National Orthopaedic Hospital
London, HA74LP
Andrew Goldberg
About this study
This study is looking at a new treatment, using the patient's own stem cells (the repair cells of the body), to see whether this can help reduce pain and promote healing of the Achilles tendon, without side effects.
Read the detailed description
Tendon disorders compromise pain free activity and often progress to chronic pain with a major impact on quality of life. More than 85,000 patients each year see their general practitioner (GP) with Achilles Tendinopathy (AT) which affects the lower leg in young and middle aged adults. The main treatment is physiotherapy, although surgery is eventually considered in 25-45%of patients, an intervention that requires several months of immobilisation and has unpredictable outcomes.
Other treatments include, shockwave therapy, Platelet Rich Plasma (PRP) (a blood injection of platelet rich plasma) and steroid injections, but other than physiotherapy non have been shown to be better than placebo. There is a need for improved nonsurgical treatments. There is an established treatment in horses that involves injection of the horses own stem cells into the tendon, which has been shown to be effective but has never been used in man. We wish to translate the technology to humans and propose a pilot phase II trial to establish the safety of stem cells implanted in diseased human tendon. We aim to study 10 patients with chronic mid substance achilles tendinopathy to assess safety as our primary outcome measure. In addition we capture clinical outcomes scores and ultrasound appearances. Other than the stem cell injection, all assessments will be non invasive. Participants will be otherwise healthy adults, aged 18-70 and recruited from routine outpatient clinics at the Royal National Orthopaedic Hospital, presenting with a painful heel, diagnosed by a specialist as Achilles tendinopathy, and having already undergone a minimum of 6 months of physiotherapy. Each participant will have 6 months follow up. This study will help inform a larger clinical trial in the future for which a further ethics application will be made.
- Conditions
- Achilles Tendinitis, Right Leg, Achilles Tendinitis, Achilles Degeneration, Achilles Tendon Thickening, Tendinopathy, Achilles Tendinitis, Left Leg
- Being tested
- Autologous Mesenchymal Stem Cells
- Keywords
- Achilles Tendinopathy, Autologous Stem Cells, Musculoskeletal
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Mesenchymal Stem CellsBiological
Also called Mesenchymal Stem Cells, Stromal Cells, Stem Cells, Cell Therapy
| Study group | Role | What they receive |
|---|---|---|
| Autologous Mesenchymal Stem Cells | Experimental | Not described Receives: Biological: Autologous Mesenchymal Stem Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary safety outcome will be the incidence rate of Serious Adverse Reaction (SAR).
The primary safety outcome is the incidence rate of SARs. This will be expressed as the proportion of participants experiencing a SAR at any time over the 24 week follow-up period. Primary outcomes will be assessed by adverse events reporting, clinical assessment and ultrasound.
Measured: 6 months
Secondary outcomes (4)
Incidence of success
The secondary efficacy outcome measure is the incidence of success at 6 months, where success is defined as a reduction of 2 or more points on VAS of pain and an increase of VISA-A score greater than the Minimum Clinically Important Difference (MCID).
Measured: 6 months
Conventional ultrasound changes from baseline
Measured: Baseline immediately before implantation and at weeks 6, 12 and 24
Ultrasound Tissue Characterisation (UTC) changes from baseline
Measured: Baseline immediately before implantation and at weeks 6, 12 and 24
Inter-observer reliability of UTC against conventional US
Measured: Baseline immediately before implantation and at weeks 6, 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Achilles Tendinitis, Right LegStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Goldberg, MBBS MD FRCSI FRCS(Tr&Orth), Principal investigator, Royal National Orthopaedic Hospital NHS Trust, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064062
- Sponsor's protocol ID
- 12/0419
- Other IDs
- 2013-000966-12
- Acronym
- ASCAT
- Status last verified
- May 2016
- First submitted
- 12 Feb 2014
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Smith RK, Korda M, Blunn GW, Goodship AE. Isolation and implantation of autologous equine mesenchymal stem cells from bone marrow into the superficial digital flexor tendon as a potential novel treatment. Equine Vet J. 2003 Jan;35(1):99-102. doi: 10.2746/042516403775467388. No abstract available.
PubMed 12553472Goldberg AJ, Zaidi R, Brooking D, Kim L, Korda M, Masci L, Green R, O'Donnell P, Smith R. Autologous Stem Cells in Achilles Tendinopathy (ASCAT): protocol for a phase IIA, single-centre, proof-of-concept study. BMJ Open. 2018 May 14;8(5):e021600. doi: 10.1136/bmjopen-2018-021600.
PubMed 29764889
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Stem Cells in Achilles Tendinopathy
- ClinicalTrials.gov ID
- NCT02064062
- Acronym / sponsor ID
- ASCAT / 12/0419
- Conditions
- Achilles Tendinitis, Right Leg, Achilles Tendinitis, Achilles Degeneration, Achilles Tendon Thickening, Tendinopathy, Achilles Tendinitis, Left Leg
- Keywords
- Achilles Tendinopathy, Autologous Stem Cells, Musculoskeletal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2018 (estimated)
- First posted
- 17 Feb 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.
This study is looking at a new treatment, using the patient's own stem cells (the repair cells of the body), to see whether this can help reduce pain and promote healing of the Achilles tendon, without side effects.
Detailed description
Tendon disorders compromise pain free activity and often progress to chronic pain with a major impact on quality of life. More than 85,000 patients each year see their general practitioner (GP) with Achilles Tendinopathy (AT) which affects the lower leg in young and middle aged adults. The main treatment is physiotherapy, although surgery is eventually considered in 25-45%of patients, an intervention that requires several months of immobilisation and has unpredictable outcomes.
Other treatments include, shockwave therapy, Platelet Rich Plasma (PRP) (a blood injection of platelet rich plasma) and steroid injections, but other than physiotherapy non have been shown to be better than placebo. There is a need for improved nonsurgical treatments. There is an established treatment in horses that involves injection of the horses own stem cells into the tendon, which has been shown to be effective but has never been used in man. We wish to translate the technology to humans and propose a pilot phase II trial to establish the safety of stem cells implanted in diseased human tendon. We aim to study 10 patients with chronic mid substance achilles tendinopathy to assess safety as our primary outcome measure. In addition we capture clinical outcomes scores and ultrasound appearances. Other than the stem cell injection, all assessments will be non invasive. Participants will be otherwise healthy adults, aged 18-70 and recruited from routine outpatient clinics at the Royal National Orthopaedic Hospital, presenting with a painful heel, diagnosed by a specialist as Achilles tendinopathy, and having already undergone a minimum of 6 months of physiotherapy. Each participant will have 6 months follow up. This study will help inform a larger clinical trial in the future for which a further ethics application will be made.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous Mesenchymal Stem Cells | Experimental | Biological: Autologous Mesenchymal Stem Cells |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged ≥18 and ≤ 70 (both males and females)
- Participants with chronic midportion AT (as defined by pain in region of AT and tender swelling in mid portion of AT (no tenderness over bony attachment to heel) with symptoms for longer than 6 months who have failed conservative treatment (at least a full course of physiotherapy) and for whom surgery is being considered
- Able to provide written informed consent
Key exclusion criteria (9 listed)
- Previous bony surgery (e.g. reconstructive pelvic osteotomy) at or in proximity to the bone marrow harvest site
- Pregnancy or lactation
- Current use of steroids, anti-tumour necrosis factor (TNF) drugs, methotrexate, or ciprofloxacin (or use within 4 weeks of assessment for eligibility)
- Positive for hepatitis B virus (HBV), Hepatitis C virus (HCV), Human Immunodeficiency Virus (HIV 1 and 2), syphilis and human t-cell leukaemia virus (HTLV)
- Previous AT surgery on the tendon to receive mesenchymal stem cell (MSC) implantation
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 Mesenchymal Stem CellsAlso: Mesenchymal Stem Cells, Stromal Cells, Stem Cells, Cell Therapy | Biological | Autologous Mesenchymal Stem Cells |
Primary outcome
The primary safety outcome will be the incidence rate of Serious Adverse Reaction (SAR).
Time frame: 6 months
The primary safety outcome is the incidence rate of SARs. This will be expressed as the proportion of participants experiencing a SAR at any time over the 24 week follow-up period. Primary outcomes will be assessed by adverse events reporting, clinical assessment and ultrasound.
4 secondary outcomes
Incidence of success
Time frame: 6 months
Conventional ultrasound changes from baseline
Time frame: Baseline immediately before implantation and at weeks 6, 12 and 24
Ultrasound Tissue Characterisation (UTC) changes from baseline
Time frame: Baseline immediately before implantation and at weeks 6, 12 and 24
Inter-observer reliability of UTC against conventional US
Time frame: Baseline immediately before implantation and at weeks 6, 12 and 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
- Background: PubMed 12553472Smith RK, Korda M, Blunn GW, Goodship AE. Isolation and implantation of autologous equine mesenchymal stem cells from bone marrow into the superficial digital flexor tendon as a potential novel treatment. Equine Vet J. 2003 Jan;35(1):99-102. doi: 10.2746/042516403775467388. No abstract available.
- Derived from this study: PubMed 29764889Goldberg AJ, Zaidi R, Brooking D, Kim L, Korda M, Masci L, Green R, O'Donnell P, Smith R. Autologous Stem Cells in Achilles Tendinopathy (ASCAT): protocol for a phase IIA, single-centre, proof-of-concept study. BMJ Open. 2018 May 14;8(5):e021600. doi: 10.1136/bmjopen-2018-021600.
- Related InfoLink provided by the sponsor.
Related trials for Achilles Tendinitis, Right Leg
Not yet recruiting
Extracorporeal Shockwave Therapy and Platelet-Rich Plasma for Midportion Achilles Tendinopathy
Achilles Injuries Tendon, Achilles Tendinopathy (AT)
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.
Andrew Goldberg, MBBS MD FRCSI FRCS(Tr&Orth) principal investigator
Royal National Orthopaedic Hospital NHS Trust, UCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Autologous Mesenchymal Stem Cells in people with Achilles Tendinitis, Right Leg and Achilles Tendinitis, run by University College, London at 1 site in United Kingdom.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 12 May 2016. 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 Kingdom. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andy Goldberg (0208 909 5825, andy.goldberg@rnoh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary safety outcome will be the incidence rate of Serious Adverse Reaction (SAR). (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02064062, which also lists 2 linked publications.
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 12 May 2016.