Bone Marrow Derived Allogeneic Mesenchymal Stromal Cells to Non-healing

Status Terminated

Clinical Trial Summary

examine safety of topical application of single dose allogeneic bone marrow derived mesenchymal stromal cells to non-healing diabetic foot ulcers

Clinical Trial Description

1.1 Trial Phase

Phase 1b

1.2 Trial Aims and Objectives

To examine the safety of topical application of a single dose of allogeneic bone marrow derived mesenchymal stromal cells (REDDSTAR ORBCEL-M) seeded in a collagen scaffold to patients with non-healing neuroischaemic diabetic foot wounds.

1.3 Patient Population

Patients with non-healing neuroischaemic diabetic foot wounds despite standard care.

1.4 Trial Setting

Steno Diabetes Center Copenhagen, Denmark and Zelo Phase I Unit, Bispebjerg Hospital, Copenhagen, Denmark.

1.5 Trial Intervention

Topical application of allogeneic bone marrow derived mesenchymal stromal cells seeded in a collagen scaffold to patients with non-healing neuroischaemic diabetic foot wounds.

1.6 Concurrent Control

Open label, uncontrolled, non-randomised, single dose study.

1.7 Sample Size

9

1.8 Method of Participant Assignment

Administration of a single dose of allogeneic bone marrow-derived mesenchymal stromal cells seeded in a collagen scaffold.

1.9 Examination Points

0, 1 week, 2 weeks, 3 weeks, 4 weeks up until 12 weeks or until complete wound closure. After the week 12 visit, or ulcer closure, whichever occurs first, each patient will return to the clinic 1 (± 2 days), 2 (± 2 days), 4 (± 3 days), 8 (±3 days), and 12 (±3days) weeks later for follow-up visits to for adverse events, assess wound, wound closure and durability.

1.10 Primary Outcome

Serious adverse events that are attributable to intervention.

1.11 Secondary Outcomes

Time to complete wound closure (defined as from treatment day 1 to the first visit when closure is documented). Absolute and percent changes in wound area from baseline, at weekly intervals throughout. Durability of wound closure as measured at 4 week intervals for 12 weeks from date of wound closure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03509870
Study type	Interventional
Source	Steno Diabetes Center Copenhagen
Contact
Status	Terminated
Phase	Phase 1
Start date	June 1, 2018
Completion date	April 1, 2020

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Bone Marrow Derived Allogeneic Mesenchymal Stromal Cells to Non-healing Diabetic Foot Wounds — REDDSTAR

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms