Health TrialsbyHealthPanel

Novel Cellular Therapy for the Treatment of Pain Associated With Chronic Pancreatitis

ConditionsChronic PancreatitisChronic Pain
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorVA Office of Research and Development

About this trial

The goal of this clinical trial is to test whether adult stem cells, called mesenchymal stem cells (MSCs) collected from the patient's bone marrow can help reduce pain caused by chronic pancreatitis and improve pancreatic function.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 75 years old, male or female

Pancreatic calcifications

Moderate or marked ductal lesions

Marked and persistent exocrine insufficiency defined as pancreatic steatorrhea markedly reduced by enzyme supplementation

Disqualifiers

Acute pancreatitis per 2012 revised Atlanta criteria (23) within the last 30 days oThe revised Atlanta classification requires that two or more of the following criteria be met for the diagnosis of acute pancreatitis: (a) abdominal pain suggestive of pancreatitis, (b) serum amylase or lipase level greater than three times the upper normal value, or (c) characteristic imaging findings.

Chronic pain syndromes other than pancreatitis that require daily use of opioids in the past 30 days.

Hemoglobin of <8.0g/dL, EGFR<60 ml/min, AST or ALT >2 times upper limit of normal, Bilirubin > 1.5 mg/dl unless the subject has confirmed Gilbert syndrome., Platelets <100,000/microliter, HbA1c >10%

Congestive Heart Failure NYHA class >1

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mesenchymal stem cells

    Drug

    Autologous bone marrow derived MSCs

  • Placebo

    Other intervention

    Controls

Treatment groups

40 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

Time frame
6 month

Secondary outcomes

1

Change in pancreatic volume measured by blinded scoring of MRI

Pancreas volume change

Time frame
Screening, 6 months and 12 months
2

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

Average Daily morphine Equivalent.

Time frame
Screening, 6 and 12 months
3

Change in quality of life

Quality of life to be measured by Promise-29-v 2.1

Time frame
Screening, 6 and 12 months
4

Change in M-Manheim Severity Index absolute score

Severity of Index absolute scores

Time frame
Screening, 6 and 12 months

Other outcomes

Sponsors and contacts

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

VA Office of Research and Development

Lead sponsor

Source ClinicalTrials.gov
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