A Phase 1/2 interventional study of allo-APZ2-DFU in Diabetic Neuropathic Ulcer, sponsored by RHEACELL GmbH & Co. KG. Completed at 7 sites in Germany. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-09-10.
Sponsored by RHEACELL GmbH & Co. KG · Phase 1/2, Interventional, and Treatment
The aim of this clinical trial is to investigate the efficacy (by monitoring the wound surface area reduction of Diabetic Foot Ulcers) and safety (by monitoring adverse events) of two doses of the allogeneic investigational medicinal product "allo-APZ2-DFU" topically administered to the wound matrix of patients with diabetic neuropathic ulcer.
This is an interventional, single arm, phase I/IIa clinical trial to investigate the efficacy and safety of allogeneic ABCB5-positive mesenchymal stem cells (MSCs) on wound healing in patients with diabetic neuropathic ulcer. Allogeneic MSCs will be isolated ex vivo and will be expanded in vitro. The Investigational medicinal product (IMP) containing the ABCB5-positive MSCs will then be applied two times (at Visit 3 and six weeks later, at Visit 10) on the wound surface of DFU.
Patients are followed up for efficacy for a period of three months starting after the first IMP application which allows to distinguish actual wound healing from transient wound coverage.
The wound healing process will be documented by standardized photography. The wound size reduction evaluation will start two weeks after the first IMP application. The quality of the wound healing process will be assessed on the basis of formation of granulation tissue, epithelialization and wound exudation.
Pain will be assessed using a numerical rating scale and quality of life will be investigated with standardized and validated questionnaires. To assess long-term safety of allo-APZ2-DFU three follow-up visits at Months 6, 9 and 12 after the first IMP application are included.
61 studies on the registry are indexed under Skin Ulcer; 14 are open to participants now.
This study's enrollment of 23 is below the median of 62 across 51 interventional studies indexed under Skin Ulcer.
Browse Skin Ulcer studies →RHEACELL GmbH & Co. KG is the lead sponsor of 11 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Application of IMP on patients wound
Biological: allo-APZ2-DFU
Suspension of ABCB5-positive mesenchymal stem cells
Percentage of wound surface area reduction
Percentage of wound surface area reduction at Week 12, or last available post-baseline measurement of weeks 4, 6 or 8, if the Week 12 measurement is missing (last observation carried forward \[LOCF\]).
Time frame: Week 12, or last available post-baseline measurement of weeks 4, 6 or 8 if the Week 12 measurement is missing.
Assessment of adverse event (AE) occurrence
All AEs occurring during the clinical trial will be registered, documented and evaluated.
Time frame: Up to 12 months
Percentage of wound surface area reduction
Percentage of wound surface area reduction will be evaluated.
Time frame: Weeks 2, 4, 6, 8 and 12 (without LOCF)
Percentage of invisible and visible wound surface area reduction
Percentage of invisible and visible wound surface area reduction will be evaluated.
Time frame: Weeks 2, 4, 6, 8 and 12 (without LOCF)
Absolute wound surface area reduction
Absolute wound surface area reduction will be evaluated.
Time frame: Weeks 2, 4, 6, 8 and 12 (without LOCF)
Absolute invisible and visible wound surface area reduction
Absolute invisible and visible wound surface area reduction will be evaluated.
Time frame: Weeks 2, 4, 6, 8 and 12 (without LOCF)
Assessment of wound infection
Wound infection will be evaluated.
Time frame: Days 1 and 2, Weeks 1, 2, 4, 6, 6.1, 6.2, 6.3, 8 and 12
Time to first complete wound closure
Time to first complete wound closure will be evaluated.
Time frame: A priori specification not possible; between baseline and week 12 post baseline
Proportion of patients achieving complete wound closure
Proportion of patients achieving complete wound closure will be evaluated.
Time frame: Weeks 2, 4, 6, 8 and 12
Time to first 30% reduction of wound surface area
Time to first 30% reduction of wound surface area will be evaluated.
Time frame: A priori specification not possible; between baseline and week 12 post baseline
Proportion of patients achieving 30% reduction of wound surface area
Proportion of patients achieving 30% reduction of wound surface area will be evaluated.
Time frame: Weeks 2, 4, 6, 8 and 12
Assessment of wound exudation, epithelialization and formation of granulation tissue
Wound exudation, epithelialization and formation of granulation tissue will be evaluated.
Time frame: Day 0 and Week 6.1 prior IMP-application, at Weeks 1, 2, 4, 6, 8 and 12
Time to amputation at target leg until Week 12
Time to amputation at target leg until week 12 will be evaluated.
Time frame: A priori specification not possible; between baseline and week 12 post baseline
Pain assessment as per numerical rating scale (NRS)
Pain assessment as per numerical rating scale (NRS) will be evaluated.
Time frame: At both Screening Visits, at Days 0, 1 and 2 and at Weeks 1, 2, 4, 6, 6.1, 6.2, 6.3, 8 and 12
Assessment of Quality of life (QoL) using the short form 36 (SF-36) questionnaire
Quality of life (QoL) using the short form 36 (SF-36) questionnaire will be evaluated.
Time frame: Screening Visit 1, Visit 3, at Weeks 4 and 12
Assessment of Dermatology-specific QoL based on the Dermatology Life Quality Index (DLQI) questionnaire
Dermatology-specific QoL based on the Dermatology Life Quality Index (DLQI) questionnaire will be evaluated.
Time frame: Screening Visit 1, Visit 3, at Weeks 4 and 12
Physical examination and vital signs
Physical examination and vital signs will be evaluated.
Time frame: Week 6.1 and Week 12
Time to amputation of target leg until month 12
Time to amputation of target leg until month 12 will be evaluated.
Time frame: A priori specification not possible; between baseline and month 12 post baseline
Plan to share: No
Ran from Nov 2017 to primary completion in Jun 2020, 31 months.
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RHEACELL GmbH & Co. KG