Health TrialsbyHealthPanel

Safety and Efficacy of Mesenchymal Stem Cells Associated With Chronic Pancreatitis Pain

ConditionsChronic PancreatitisChronic Pain
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMedical University of South Carolina

About this trial

This protocol aims to test whether an infusion of allogeneic bone marrow-derived mesenchymal stromal cells (BM-MSCs) can reduce pain associated with chronic pancreatitis (CP) and explore potential mechanisms of MSC action.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 75 years old, male or female

Definite chronic pancreatitis, using M-ANNHEIM criteria

Patients who are diagnosed with painful CP for more than 6 months may be constant or may have been waxing and waning/remitting.

Baseline Izbicki pain score > 30

Disqualifiers

Acute pancreatitis per 2012 revised Atlanta criteria within the last 30 days.

abdominal pain suggestive of pancreatitis,

serum amylase or lipase level greater than three times the upper normal value, or

characteristic imaging findings.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mesenchymal Stem Cells

    Drug

    Autologous bone marrow derived MSCs

  • Other: Placebo

    Other intervention

    Control

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Experimental CohortExperimental treatment 1 intervention
Group B: Validation CohortPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Izbicki pain score (M6 vs. Baseline)

Change in pain as measured by Izbicki pain scores, a validated score for pain in chronic pancreatitis, consist of 4 questions, with a range of 0 (no pain) to 100 (severe, debilitating pain).

Time frame
6 months

Secondary outcomes

1

Change in pancreatic volume measured by blinded scoring of MRI

Pancreas volume change

Time frame
Screening, 6 month
2

Change in opioid use as measured in average daily morphine equivalents.

Average Daily morphine Equivalent

Time frame
Screening, 1 month, 3 month, 6 month
3

Changes in quality of life

Quality of life to be measured by Promise-29-v 2.1 (with generated T-score for each domain)

Time frame
Screening, 1 month, 3 month, 6 month
4

Change in M-Manheim Severity Index absolute score

Severity of Index absolute scores (with lowest severity 0 and highest severity 24 points)

Time frame
Screening, 1 month, 3 month, 6 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
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